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Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00040846
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH), National Cancer Institute (NCI) (NIH)
60
Enrollment
7
Locations
1
Arm
97
Actual Duration (Months)
8.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase II trial studies the side effects and the best dose of alemtuzumab when given together with fludarabine phosphate and low-dose total body irradiation (TBI) and how well it works before donor stem cell transplant in treating patients with hematological malignancies. Giving chemotherapy and low-dose TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF) after transplant may stop this from happening.

Condition or Disease Intervention/Treatment Phase
  • Biological: alemtuzumab
  • Drug: fludarabine phosphate
  • Radiation: total-body irradiation
  • Procedure: allogeneic hematopoietic stem cell transplantation
  • Procedure: peripheral blood stem cell transplantation
  • Drug: mycophenolate mofetil
  • Drug: cyclosporine
 Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine whether stable allogeneic engraftment from related and unrelated human leukocyte antigen (HLA)-mismatched stem cell donors can be safely established using a non-myeloablative conditioning regimen plus escalating doses of the anti-CD52 monoclonal antibody (mAb) Campath (alemtuzumab) in patients with hematologic malignancies.
SECONDARY OBJECTIVES:

  1. Evaluate the risk of occurrence of acute and chronic graft-vs-host disease (GVHD).

  2. Evaluate the risk/incidence of infections.

  3. Determine whether engraftment can be maintained with a single dose fludarabine, donor lymphocyte infusion (DLI) and continued MMF/CSP.

  4. Evaluate the risk for disease progression and relapse.

OUTLINE: This is a dose-escalation study of alemtuzumab.

CONDITIONING REGIMEN: Patients receive alemtuzumab intravenously (IV) over 2 hours on days -8 to -5 and fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.

HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT): Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

IMMUNOSUPPRESSION: Patients receive CSP IV or orally (PO) twice daily (BID) on days -3 to 180 with taper to day 365 and MMF PO thrice daily (TID) on days 0-100 with taper to day 156.

After completion of study treatment, patients are followed up periodically.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Campath® [Alemtuzumab] Dose Escalation, Low-Dose TBI and Fludarabine Followed by HLA Class I Mismatched Donor Stem Cell Transplantation for Patients With Hematologic Malignancies - A Multi-Center Trial
Actual Study Start Date :
Nov 1, 2001
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (dose-escalation of alemtuzumab, HSCT)

CONDITIONING REGIMEN: Patients receive alemtuzumab IV over 2 hours on days -8 to -5 and fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.

Biological: alemtuzumab
Given IV
Other Names:
  • anti-CD52 monoclonal antibody
  • Campath-1H
  • MoAb CD52
  • Monoclonal Antibody Campath-1H
  • Monoclonal Antibody CD52

    • Drug: fludarabine phosphate
    Given IV
    Other Names:
  • 2-F-ara-AMP
  • Beneflur
  • Fludara

    • Radiation: total-body irradiation
    Undergo TBI
    Other Names:
  • TBI

    • Procedure: allogeneic hematopoietic stem cell transplantation
    Undergo allogeneic HSCT

    Procedure: peripheral blood stem cell transplantation
    Undergo allogeneic peripheral blood stem cell transplantation
    Other Names:
  • PBPC transplantation
  • PBSC transplantation
  • peripheral blood progenitor cell transplantation
  • transplantation, peripheral blood stem cell

    • Drug: mycophenolate mofetil
    Given PO
    Other Names:
  • Cellcept
  • MMF

    • Drug: cyclosporine
    Given IV or PO
    Other Names:
  • ciclosporin
  • cyclosporin
  • cyclosporin A
  • CYSP
  • Sandimmune

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate the Risk of Transplant Related Mortality. [100 days after transplant]

      Percentage patients with Day 100 transplant related mortality.

    2. Evaluate the Risk of Occurrence of Acute and Chronic GVHD [1 year after transplant]

      Percentage patients who developed acute/chronic GVHD. aGVHD Stages Skin: a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

    3. Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%. [100 days after transplant]

      Mixed chimerism will be defined as the detection of donor T cells (CD3+) and granulocytes (CD 33+), as a proportion of the total T cell and granulocyte population, respectively, of greater than 5% and less than 95% in the peripheral blood. Full donor chimerism is defined as > 95% donor CD3+ T cells.

    Secondary Outcome Measures

    1. Evaluate the Risk/Incidence of Infections [100 days after transplant]

      Percentage patients who experienced infections within 100 days post-transplant.

    2. Evaluate the Risk for Disease Progression and Relapse [1 year after transplant]

      Percentage patients who relapsed/progressed within 1 year post-transplant.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 74 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients must be not eligible for conventional transplants and must have disease expected to be stable for at least 100 days without chemotherapy; patients with hematologic malignancies treatable with hematopoietic stem cell transplant (HSCT) or with a B cell malignancy except those treatable with autologous transplant will be included

    • Aggressive non-Hodgkin lymphomas (NHLs) and Other Histologies Such as Diffuse large B cell NHL

    • Patients with primary refractory or relapsed disease not eligible for an autologous transplant

    • Patients are eligible following an autologous transplant in remission or in relapse

    • Planned tandem transplant is allowed for patients at high risk of relapse

    • Low grade NHL with < 6 months duration of complete remission (CR) between courses of conventional therapy

    • Mantle Cell NHL may be treated in first CR

    • Chronic lymphocytic leukemia (CLL) - Must have failed 2 lines of conventional therapy and be refractory to fludarabine

    • Hodgkin disease (HD) - Must have received and failed frontline therapy; patients must have had a prior autologous transplant or were not eligible for autologous transplant; planned tandem transplants are allowed for patients at high risk of relapse

    • Multiple myeloma (MM) - Must have received prior chemotherapy and a prior autologous transplant, unless autologous transplant was not possible; planned tandem transplants are allowed for patients at high risk of relapse

    • Acute myeloid leukemia (AML) - Must have < 5% marrow blasts at the time of transplant

    • Acute lymphocytic leukemia (ALL) - Must have < 5% blasts at the time of transplant

    • Chronic myeloid leukemia (CML) - Patients will be accepted beyond chronic phase 1 (CP1) if they have received previous myelosuppressive chemotherapy or HSCT, and have < 5% marrow blasts at time of transplant

    • Myelodysplastic (MDS)/Myeloproliferative disorders - Must have failed previous myelosuppressive chemotherapy or HSCT, and have < 5% marrow blasts at time of transplant

    • Waldenstrom's Macroglobulinemia - Must have failed 2 courses of therapy

    • Patients < 12 years old must be approved by the Fred Hutchinson Cancer Research Center (FHCRC) principal investigator (PI)

    • Patients who refuse to be treated on a conventional transplant protocol; for this inclusion, criteria transplants must be approved by both the participating institution´s patient review committee such as the Patient Care Conference (PCC) at the FHCRC and the FHCRC principal investigator

    • Patients with related or unrelated donors for whom

    • The best available match is a HLA class II DRB1 and DQB1 matched donor incompatible for any single serologically detectable class I HLA-A, -B, -C mismatch; one additional allele level class I mismatch is allowed OR any combination of 2 allele level mismatches (if typed at the molecular level)

    • There is a likelihood of rapid disease progression while HLA typing and results of a preliminary search and the donor pool suggests that a 10/10 HLA-A, B, C, DRB1 and DQB1 matched unrelated donor will not be found

    • There is no HLA-A, -B or -C one locus allelic mismatched related donor available

    • There is no indication for an autologous transplantation as a treatment option

    • DONOR: Related or unrelated donors who are matched for HLA-DRB1 and DQB1 alleles (must be defined by high resolution typing), and who are mismatched for:

    • Any single serologically detectable HLA-A or B or C antigen +/- 1 allele or

    • Any combination of two HLA-A, -B, or -C alleles (if prospectively typed at molecular level)

    Exclusion Criteria:

    • Patients who are homozygous at the mismatched major histocompatibility complex (MHC) class I locus

    • A positive cross-match exists between the donor and recipient

    • Patients with rapidly progressive intermediate or high grade NHL

    • Presence of circulating leukemic blasts (in the peripheral blood) detected by standard pathology for patients with AML, ALL or CML

    • Life expectancy severely limited by diseases other than malignancy

    • Central nervous system (CNS) involvement with disease refractory to intrathecal chemotherapy

    • Fertile men or women unwilling to use contraceptives during and for up to 12 months post treatment

    • Female patients who are pregnant or breast-feeding

    • Human immunodeficiency virus (HIV) positive patients

    • Patients with active non-hematologic malignancies (except non-melanoma skin cancers)

    • Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a > 20% risk of disease recurrence

    • Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month

    • Patients with active bacterial or fungal infections unresponsive to medical therapy

    • Patients with the following organ dysfunction symptomatic coronary artery disease or ejection fraction < 35% or other cardiac failure requiring therapy; ejection fraction is required if the patient is > 50 years of age, or history of cardiac disease or anthracycline exposure

    • Diffusion capacity of carbon monoxide (DLCO) < 35%; total lung capacity (TLC) < 35%; or forced expiratory volume in one second (FEV1) < 35% and/or receiving supplementary continuous oxygen

    • Patients with clinical or laboratory evidence of liver disease would be evaluated for the cause of liver disease, its clinical severity in terms of liver function, bridging fibrosis, and the degree of portal hypertension; patients will be excluded if they are found to have fulminant liver failure; cirrhosis of the liver with evidence of portal hypertension; alcoholic hepatitis; esophageal varices; a history of bleeding esophageal varices; hepatic encephalopathy; uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time; ascites related to portal hypertension; bacterial or fungal liver abscess; biliary obstruction; chronic viral hepatitis with total serum bilirubin >3 mg/dL; or symptomatic biliary disease

    • Patients with poorly controlled hypertension on multiple antihypertensives

    • Karnofsky score < 70 for adult patients

    • Lansky-Play Performance Score < 50 for pediatric patients

    • DONOR: Bone marrow (BM) donors

    • DONOR: Donors who are HIV-positive and/or, medical conditions that would result in increased risk for granulocyte colony-stimulating factor (G-CSF) mobilization and harvest of peripheral blood stem cell (PBSC)

    • DONOR: Donors < 12 years of age

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado United States 80218
    2 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    3 LDS Hospital Salt Lake City Utah United States 84143
    4 VA Puget Sound Health Care System Seattle Washington United States 98101
    5 Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle Washington United States 98109
    6 Froedtert Memorial Lutheran Hospital, Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    7 University of Torino Torino Italy 10126

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center
    • National Heart, Lung, and Blood Institute (NHLBI)
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Brenda Sandmaier, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brenda Sandmaier, Principal Investigator, Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00040846
    Other Study ID Numbers:
    • 1591.00
    • NCI-2011-00471
    • 1591.00
    • P30CA015704
    • P01CA018029
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jan 29, 2020
    Last Verified:
    Jan 1, 2020
    Additional relevant MeSH terms:
    Burkitt Lymphoma
    Mycoses
    Lymphoma
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Multiple Myeloma
    Lymphoma, Follicular
    Lymphoma, Non-Hodgkin
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Lymphoma, B-Cell
    Leukemia, Lymphocytic, Chronic, B-Cell
    Hodgkin Disease
    Lymphoma, Mantle-Cell
    Leukemia, Myelogenous, Chronic, BCR-ABL Positive
    Lymphoma, B-Cell, Marginal Zone
    Lymphoma, T-Cell
    Lymphoma, T-Cell, Peripheral
    Lymphoma, Large B-Cell, Diffuse
    Lymphoma, Large-Cell, Immunoblastic
    Plasmablastic Lymphoma
    Mycosis Fungoides
    Sezary Syndrome
    Leukemia, T-Cell
    Lymphoma, T-Cell, Cutaneous
    Leukemia-Lymphoma, Adult T-Cell
    Waldenstrom Macroglobulinemia
    Lymphoma, Large-Cell, Anaplastic
    Leukemia, Hairy Cell
    Leukemia, Myeloid, Chronic-Phase
    Lymphomatoid Granulomatosis
    Lymphoma, Extranodal NK-T-Cell
    Leukemia, Large Granular Lymphocytic
    Myelodysplastic Syndromes
    Myeloproliferative Disorders
    Immunoblastic Lymphadenopathy
    Myelodysplastic-Myeloproliferative Diseases
    Syndrome
    Recurrence
    Cyclosporine
    Mycophenolic Acid
    Antineoplastic Agents, Immunological
    Alemtuzumab
    Fludarabine
    Fludarabine phosphate
    Antibodies
    Immunoglobulins
    Antibodies, Monoclonal
    Cyclosporins

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
    Arm/Group Description CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    Period Title: Overall Study
    STARTED 60 0 0 0 0 0
    COMPLETED 60 0 0 0 0 0
    NOT COMPLETED 0 0 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath) Total
    Arm/Group Description CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV Total of all reporting groups
    Overall Participants 60 0 0 0 0 0 60
    Age (Count of Participants)
    <=18 years
    1
    1.7%
    1
    Infinity
    Between 18 and 65 years
    52
    86.7%
    52
    Infinity
    >=65 years
    7
    11.7%
    7
    Infinity
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    56.7
    56.7
    Sex: Female, Male (Count of Participants)
    Female
    15
    25%
    15
    Infinity
    Male
    45
    75%
    45
    Infinity
    Region of Enrollment (participants) [Number]
    United States
    60
    100%
    60
    Infinity

    Outcome Measures

    1. Primary Outcome
    Title Evaluate the Risk of Transplant Related Mortality.
    Description Percentage patients with Day 100 transplant related mortality.
    Time Frame 100 days after transplant

    Outcome Measure Data

    Analysis Population Description
    No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
    Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
    Arm/Group Description CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    Measure Participants 60 0 0 0 0 0
    Number [percentage of participants]
    20
    33.3%
    2. Primary Outcome
    Title Evaluate the Risk of Occurrence of Acute and Chronic GVHD
    Description Percentage patients who developed acute/chronic GVHD. aGVHD Stages Skin: a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
    Time Frame 1 year after transplant

    Outcome Measure Data

    Analysis Population Description
    No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
    Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
    Arm/Group Description CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    Measure Participants 60 0 0 0 0 0
    Grade III-IV aGVHD
    23.3
    38.8%
    cGVHD
    41.7
    69.5%
    3. Primary Outcome
    Title Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%.
    Description Mixed chimerism will be defined as the detection of donor T cells (CD3+) and granulocytes (CD 33+), as a proportion of the total T cell and granulocyte population, respectively, of greater than 5% and less than 95% in the peripheral blood. Full donor chimerism is defined as > 95% donor CD3+ T cells.
    Time Frame 100 days after transplant

    Outcome Measure Data

    Analysis Population Description
    No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
    Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
    Arm/Group Description CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    Measure Participants 60 0 0 0 0 0
    CD3 - Graft rejection
    3.3
    5.5%
    CD3 - Mixed chimerism
    18.3
    30.5%
    CD3 - Full donor chimerism
    70
    116.7%
    CD3 - Unknown
    8.33
    13.9%
    CD33 - Graft Rejection
    1.7
    2.8%
    CD33 - Mixed chimerism
    3.3
    5.5%
    CD33 - Full donor chimerism
    80
    133.3%
    CD33 - Unknown
    15
    25%
    4. Secondary Outcome
    Title Evaluate the Risk/Incidence of Infections
    Description Percentage patients who experienced infections within 100 days post-transplant.
    Time Frame 100 days after transplant

    Outcome Measure Data

    Analysis Population Description
    No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
    Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
    Arm/Group Description CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    Measure Participants 60 0 0 0 0 0
    Number [percentage of participants]
    91.7
    152.8%
    5. Secondary Outcome
    Title Evaluate the Risk for Disease Progression and Relapse
    Description Percentage patients who relapsed/progressed within 1 year post-transplant.
    Time Frame 1 year after transplant

    Outcome Measure Data

    Analysis Population Description
    No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
    Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
    Arm/Group Description CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    Measure Participants 60 0 0 0 0 0
    Number [percentage of participants]
    21.7
    36.2%

    Adverse Events

    Time Frame AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
    Adverse Event Reporting Description No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
    Arm/Group Title Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
    Arm/Group Description CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
    All Cause Mortality
    Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 24/60 (40%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
    Cardiac disorders
    Cardiac troponin I increased 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Heart failure 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Gastrointestinal disorders
    Gastric perforation 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    General disorders
    Multi-organ failure 4/60 (6.7%) 4 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Immune system disorders
    GVHD 8/60 (13.3%) 8 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Infections and infestations
    Sepsis 5/60 (8.3%) 5 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Secondary Malignancy 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Nervous system disorders
    Leukoencephalopathy 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Pleural hemorrhage 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Respiratory failure 3/60 (5%) 3 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Vascular disorders
    Thromboembolic event 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Other (Not Including Serious) Adverse Events
    Dose Level 1 (No Campath) Dose Level 2 (0.025 mg/kg/Day Campath) Dose Level 3 (0.050 mg/kg/Day Campath) Dose Level 4 (0.10 mg/kg/Day Campath) Dose Level 5 (0.20 mg/kg/Day Campath) Dose Level 6 (0.40 mg/kg/Day Campath)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 33/60 (55%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders - Other (Coagulopathy) 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Febrile neutropenia 2/60 (3.3%) 2 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Hemolysis 2/60 (3.3%) 2 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Anemia 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Blood and lymphatic System Disorder - Other (Hemoptysis) 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Cardiac disorders
    Atrial fibrillation 2/60 (3.3%) 3 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Myocardial infaction 3/60 (5%) 3 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Ventricular arrhythmia 3/60 (5%) 3 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Heart Failure 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Gastrointestinal disorders
    Abdominal pain 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Diarrhea 2/60 (3.3%) 3 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Gastric hemorrhage 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Immune system disorders
    Anaphylaxis 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Infections and infestations
    Infections and infestations - Other (Blood) 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Lung infection 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Sepsis 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Injury, poisoning and procedural complications
    Spinal injury 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Investigations
    Aspartate aminotransferase increased 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Blood bilirubin increased 13/60 (21.7%) 13 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Creatinine increased 5/60 (8.3%) 5 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Neutrophil count decreased 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Metabolism and nutrition disorders
    Anorexia 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Dehydration 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Hyperglycemia 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Hyperkalemia 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Hypokalemia 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Hyponatremia 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Tumor lysis syndrome 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Nervous system disorders
    Ataxia 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Leukoencephalopathy 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Renal and urinary disorders
    Acute kidney injury 2/60 (3.3%) 3 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Renal and urinary disorders - Other (BUN increased) 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Respiratory, thoracic and mediastinal disorders
    Adult respiratory distress syndrome 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Hypoxia 10/60 (16.7%) 12 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Pleural effusion 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Respiratory failure 2/60 (3.3%) 2 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Bronchopulmonary hemorrhage 1/60 (1.7%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Vascular disorders
    Capillary leak syndrome 2/60 (3.3%) 2 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Hypertension 3/60 (5%) 3 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Hypotension 4/60 (6.7%) 4 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
    Thromboembolic event 3/60 (5%) 3 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Brenda M. Sandmaier
    Organization Fred Hutchinson Cancer Research Center
    Phone (206) 667-4961
    Email bsandmai@fhcrc.org
    Responsible Party:
    Brenda Sandmaier, Principal Investigator, Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00040846
    Other Study ID Numbers:
    • 1591.00
    • NCI-2011-00471
    • 1591.00
    • P30CA015704
    • P01CA018029
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jan 29, 2020
    Last Verified:
    Jan 1, 2020