Fludarabine Phosphate, Melphalan, Total-Body Irradiation, Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Bone Marrow Failure Disorders
Study Details
Study Description
Brief Summary
This clinical trial is studying how well giving fludarabine phosphate and melphalan together with total-body irradiation followed by donor stem cell transplant works in treating patients with hematologic cancer or bone marrow failure disorders. Giving low doses of chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells or abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect)
Detailed Description
PRIMARY OBJECTIVES:
- To determine the transplant related mortality (TRM) of this reduced intensity transplantation (RIT) combination in a patient population that is usually not eligible for a full myeloablative allogeneic transplant.
SECONDARY OBJECTIVES:
- To evaluate engraftment, safety, clinical response, evidence of graft-versus-malignancy effect/graft-versus-host disease (GVHD) and overall outcomes of treatment with our RIT regimen across a variety of hematological conditions.
OUTLINE: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.
Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.
After completion of study treatment, patients are followed up periodically.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (Reduced intensity allogeneic stem cell transplant) Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan. |
Drug: fludarabine phosphate
Given IV
Other Names:
Drug: melphalan
Given IV
Other Names:
Radiation: total-body irradiation
Undergo total-body irradiation
Other Names:
Procedure: allogeneic hematopoietic stem cell transplantation
Undergo allogeneic stem cell transplantation
Biological: anti-thymocyte globulin
Given IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Day 100 TRM [First 100 days]
Day 100 Treatment Related Mortality An exact 95% confidence interval will be provided.
Secondary Outcome Measures
- Median Time to ANC Engraftment [Days 30]
Median Time to ANC Engraftment Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
- Median Time to Platelet Engraftment [Day 100]
Median Time to Platelet Engraftment Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
- Rate of Complete Donor Chimerism - Blood [Day 30]
Rate of Complete Donor Chimerism - Blood Summarized using standard descriptive statistics.
- Rate of Complete Donor Chimerism - Blood [Day 100]
Rate of Complete Donor Chimerism - Blood Summarized using standard descriptive statistics.
- Acute GVHD Grade III-IV [Up to day 100]
Acute GVHD grade III-IV Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
- 1 yr Extenstive Chronic GVHD [Up to 4.5 years]
1 yr Extensive Chronic GVHD Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
- 3 yr Overall Survival [Up to 4.5 years]
3 yr Overall Survival estimated using the Kaplan-Meier method.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of a histology documented hematologic malignancy or marrow disorder
-
Bone marrow failure disorders and other non-malignant hematologic or immunologic disorders:
-
Acquired bone marrow failure disorders include aplastic anemia, paroxysmal nocturnal hemoglobinuria (PNH):
-
Primary allogeneic hematopoietic stem cell transplantation (HSCT) is appropriate for selected patients with severe aplastic anemia; however, patients with aplastic anemia must have failed at least one cycle of standard immunosuppressive therapy with calcineurin inhibitor plus anti-thymocyte globulin (ATG) if a fully-matched donor is not available
-
Patients with PNH must have a history of thrombosis related to PNH
-
Hereditary bone marrow failure disorders include Fanconi anemia or related chromosomal breakage syndrome dyskeratosis congenita, Diamond-Blackfan anemia, Shwachman-Diamond syndrome, Kostmann syndrome, congenital amegakaryocytic thrombocytopenia:
-
Fanconi anemia or related chromosomal breakage syndrome: positive chromosome breakage analysis using diepoxybutane (DEB) or mitomycin C if applicable
-
Dyskeratosis: diagnosis is supported by using either telomerase reverse transcriptase (TERC) gene mutation in autosomal dominant Dyskeratosis Congenita or Xlinked DKC1 gene mutation
-
Other non-malignant hematologic or immunologic disorders that require transplantation
-
Quantitative or qualitative congenital platelet disorders (including but not limited to congenital amegakaryocytopenia, absent-radii syndrome, Glanzmann's thrombasthenia)
-
Quantitative or qualitative congenital neutrophil disorders (including but not limited to chronic granulomatous disease, congenital neutropenia)
-
Congenital primary immunodeficiencies (including but not limited to Severe Combined Immunodeficiency Syndrome, Wiskott-Aldrick syndrome, CD40 ligand deficiency, T-cell deficiencies)
-
Acute leukemias:
-
Subjects must be ineligible for conventional myeloablative transplantation;
-
Resistant or recurrent disease after at least one standard combination chemotherapy regime or first remission patients at high risk of relapse OR First remission patients at high risk of relapse:
-
Acute myeloid leukemia (AML)- antecedent myelodysplastic syndrome, secondary AML, high risk cytogenetic abnormalities or normal cytogenetics with high-risk molecular features (e.g. Flt3-ITD mutation, mixed-lineage leukemia [MLL], wildtype NPM1);
-
Acute lymphocytic leukemia (ALL)- high or standard risk ALL
-
Chronic Myeloid Leukemia (CML):
-
Chronic phase (intolerant or unresponsive to imatinib and/or other tyrosine kinase inhibitors), second chronic phase or accelerated phase who are ineligible for conventional myeloablative transplantation
-
Myeloproliferative and myelodysplastic syndromes (MDS):
-
Myelofibrosis (with/without splenectomy) with intermediate to high risk features
-
Advanced polycythemia vera not responding to standard therapy
-
MDS with an international prostate symptom score (IPSS) score of Int-2 or higher
-
MDS with lower IPSS scores Int-1 or less with severe clinical features such as severe neutropenia or thrombocytopenia or high risk chromosome abnormalities such as monosomy 7
-
Secondary massively parallel signature sequencing (MPSS) with any IPSS scores
-
Chronic myelomoncytic leukemia
-
Lymphoproliferative disease:
-
Chronic lymphocytic leukemia (CLL), low-grade non-Hodgkin lymphoma (NHL) (recurrent or persistent) fludarabine refractory or with less than 6 months duration of complete response (CR) between courses of conventional therapy
-
Multiple myeloma, progressive disease after autologous stem cell transplant or as planned tandem (allogeneic transplant after prior autologous stem cell transplant)
-
Waldenstroms macroglobulinemia (failed one standard regimen)
-
High grade NHL and diffuse large B-cell lymphoma (DLBCL)
-
Not eligible for conventional myeloablative HSCT OR failed autologous HSCT
-
First remission lymphoblastic lymphoma, or small, non-cleaved cell lymphoma or mantle cell lymphoma
-
Hodgkin disease:
-
Relapsed or refractory after front-line therapy
-
Failed or were not eligible for autologous transplantation
-
Failed prior autotransplant
-
Age >= 3 and =< 75 years for blood and bone marrow transplants and age >= 3, < 60 for cord blood transplants
-
No serious uncontrolled psychiatric illness
-
No concomitant active malignancy other than non-melanoma skin cancer
-
Non-pregnant and non-nursing women (women or men with reproductive potential should agree to use an effective means of birth control)
-
Patients may have received prior autologous bone marrow transplant (BMT) or prior myeloablative allogeneic BMT (at least 60 days have elapsed)
-
At least 2 weeks since prior chemotherapy, radiation treatment and/or surgery
-
Informed consent
-
DONOR: Permissible HLA matching: Related donors- single antigen mismatch at HLA A, B or DRB 1; unrelated donors- a single antigen mismatch at HLA A, B, or C, +/- additional single allele level mismatch at A, B, C or DRB1; cord blood >= 4 out of 6 antigen match at HLA A, B, DRB1)
-
DONOR: Compatibility at the four most informative HLA loci: A, B, C and DRB1 are important for reducing the risk of GVHD and successful transplant outcomes; the A, B, C and DRB1 loci comprise 8 possible alleles (a haplotype being inherited from each parent); one additional locus, HLA-DQ, is also typed to ascertain haplotypes and assist in the search for a compatible donor; however mismatching at DQ has not been shown to be associated with adverse outcomes; high resolution molecular typing (at the allele level) is now the standard of care for unrelated donor searches and allows greater refinement of the search strategy
-
DONOR: Matched related donor: a single antigen mismatch at A, B, or the DR transplant from a family member is associated with a higher risk of GVHD but similar overall survival when compared to full identity at these 3 regions; related donor/recipient pairs must be matched at 5 of 6 HLA antigens (A, B, DRBl)
-
DONOR: Unrelated donor: when evaluating patients for unrelated donor transplant, a higher degree of matching is preferred due to minimize the risk of GVHD; the A, B, C, DRB1 and DQ loci, comprising 10 possible alleles, will be typed routinely for all unrelated transplants; given the higher risk of TRM in mismatched transplants, RIT is often the best way to mitigate the risk; evolving data from the National Marrow Donor Program now makes it possible to estimate the risks of donor-recipient HLA mismatch at the allele or antigen level; the higher risk from HLA-mismatching must be carefully assessed with respect to the clinical urgency and the patient's risk by the transplant physician; antigen level mismatches at DQ are inconsequential to transplant outcomes and are ignored with respect to donor selection for the purposes of this protocol, with matching requirements confined to the 8 loci involving HLA A, B, C and DRB1; for the purpose of this protocol, a single antigen mismatch at HLA A, B, or C, with or without additional single allele level mismatch may participate in this protocol for voluntary unrelated donors (blood or marrow); patients must be at least antigen-level matched at DRB1
-
DONOR: If a patient has no suitable family donor matched for 5 of 6 HLA antigens (A, B, DRB1) and no suitable unrelated donor is identified or for reasons of urgency, the patient can be considered a candidate for cord blood transplant, provided a cord blood donor is identified with a >= 4 out of 6 antigen match at HLA A, B, DRB1 antigens; the cord blood product must provide a minimum of 2 x 10^7 nucleated cells/kg, test negative for HIV and Hepatitis A, Band C, and sterility assays have no growth; the cord blood products are located through the National Marrow Donor Program, the American Registry, or the Bone Marrow Donor Worldwide or other established registries, and may be stored in the N.Y Placental Cord Blood Bank, the St. Louis Cord Blood Bank, or any of the established, registered International blood and marrow banks
-
DONOR: Donor must be healthy and have nonreactive test results for all infectious disease assays as required by state and federal regulations; donors who screen seropositive for hepatitis and/or syphilis must be cleared by infectious disease consultation
-
DONOR: The donor must have no uncontrolled cardiopulmonary, renal, endocrine, hepatic or psychiatric disease to render donation unsafe
-
DONOR: The donor must be able to give informed consent for peripheral blood stem cell collection or bone marrow collection
-
DONOR: Syngeneic donors are not eligible
-
DONOR: Donors who have poor peripheral venous access, may require central venous line placement for stem cell apheresis
Exclusion Criteria:
-
Uncontrolled central nervous system (CNS) disease (for hematologic malignancies)
-
Karnofsky (adult) or Lansky (for =< 16 years) performance status =< 50%
-
Diffusing capacity of the lung for carbon monoxide (DLCO) less than 40% predicted, corrected for hemoglobin (Hb) and/or alveolar ventilation
-
Cardiac: left ventricular ejection fraction less than 40%
-
Bilirubin >= 3 x upper limit of normal
-
Liver alkaline phosphatase >= 3 x upper limit of normal
-
Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvate transaminase (SGPT) >= 3 x upper limit of normal
-
Child's class B and C liver failure
-
Calculated creatinine clearance < 40 cc/min by the modified Cockcroft-Gault formula for adults or the Schwartz formula for pediatrics
-
Patients who have received maximally allowed doses (given in 2 Gy fractions, or equivalent) of previous radiation therapy to various organs as follows:
-
Mediastinum 40 Gy
-
Heart (any volume) 36 Gy
-
Whole lungs 12 Gy
-
Small bowel (any volume) 46 Gy
-
Kidneys 12 Gy
-
Whole liver 20 Gy
-
Spinal cord (any volume) 36 Gy
-
Whole brain 30 Gy Enrollment of patients who previously receive higher than allowed dose of radiation to a small volume of lungs, liver, and brain will be determine by the discretion of the radiation oncologist on the study
-
Uncontrolled diabetes mellitus, cardiovascular disease, active serious infection or other condition which, in the opinion of treating physician, would make this protocol unreasonably hazardous for the patient
-
Human immunodeficiency virus (HIV) positive
-
Patients who in the opinion of the treating physician are unlikely to comply with the restrictions of allogeneic stem cell transplantation based on formal psychosocial screening
-
Females of childbearing potential with a positive pregnancy test
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
Sponsors and Collaborators
- Roswell Park Cancer Institute
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: George Chen, Roswell Park Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- I 118807
- NCI-2009-01508
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) |
|---|---|
| Arm/Group Description | Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan. |
| Period Title: Overall Study | |
| STARTED | 62 |
| COMPLETED | 61 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) |
|---|---|
| Arm/Group Description | Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan. |
| Overall Participants | 62 |
| Age (Count of Participants) | |
| <=18 years |
2
3.2%
|
| Between 18 and 65 years |
43
69.4%
|
| >=65 years |
17
27.4%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
54.6
(14.3)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
29
46.8%
|
| Male |
33
53.2%
|
Outcome Measures
| Title | Day 100 TRM |
|---|---|
| Description | Day 100 Treatment Related Mortality An exact 95% confidence interval will be provided. |
| Time Frame | First 100 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated and eligible patients |
| Arm/Group Title | Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) |
|---|---|
| Arm/Group Description | Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan. |
| Measure Participants | 61 |
| Number (95% Confidence Interval) [percentage of participants] |
8.44
13.6%
|
| Title | Median Time to ANC Engraftment |
|---|---|
| Description | Median Time to ANC Engraftment Summarized using standard descriptive statistics along with corresponding 95% confidence intervals. |
| Time Frame | Days 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated and eligible patients |
| Arm/Group Title | Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) |
|---|---|
| Arm/Group Description | Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan. |
| Measure Participants | 61 |
| Median (Full Range) [Days] |
16.5
|
| Title | Median Time to Platelet Engraftment |
|---|---|
| Description | Median Time to Platelet Engraftment Summarized using standard descriptive statistics along with corresponding 95% confidence intervals. |
| Time Frame | Day 100 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated and eligible patients |
| Arm/Group Title | Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) |
|---|---|
| Arm/Group Description | Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan. |
| Measure Participants | 61 |
| Median (Full Range) [Days] |
17.0
|
| Title | Rate of Complete Donor Chimerism - Blood |
|---|---|
| Description | Rate of Complete Donor Chimerism - Blood Summarized using standard descriptive statistics. |
| Time Frame | Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated and eligible patients, who were able to complete testing |
| Arm/Group Title | Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) |
|---|---|
| Arm/Group Description | Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan. |
| Measure Participants | 44 |
| Number [percentage of participants] |
89
143.5%
|
| Title | Rate of Complete Donor Chimerism - Blood |
|---|---|
| Description | Rate of Complete Donor Chimerism - Blood Summarized using standard descriptive statistics. |
| Time Frame | Day 100 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated and eligible patients, who were able to complete testing |
| Arm/Group Title | Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) |
|---|---|
| Arm/Group Description | Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan. |
| Measure Participants | 49 |
| Number [percentage of participants] |
94
151.6%
|
| Title | Acute GVHD Grade III-IV |
|---|---|
| Description | Acute GVHD grade III-IV Summarized using standard descriptive statistics along with corresponding 95% confidence intervals. |
| Time Frame | Up to day 100 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated and eligible patients |
| Arm/Group Title | Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) |
|---|---|
| Arm/Group Description | Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan. |
| Measure Participants | 61 |
| Number (95% Confidence Interval) [percentage of participants] |
27
43.5%
|
| Title | 1 yr Extenstive Chronic GVHD |
|---|---|
| Description | 1 yr Extensive Chronic GVHD Summarized using standard descriptive statistics along with corresponding 95% confidence intervals. |
| Time Frame | Up to 4.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated and eligible who survived to day 100 and were eligible to get chronic GVHD |
| Arm/Group Title | Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) |
|---|---|
| Arm/Group Description | Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan. |
| Measure Participants | 53 |
| Number (95% Confidence Interval) [percentage of participants] |
60
96.8%
|
| Title | 3 yr Overall Survival |
|---|---|
| Description | 3 yr Overall Survival estimated using the Kaplan-Meier method. |
| Time Frame | Up to 4.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated and eligible patients |
| Arm/Group Title | Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) |
|---|---|
| Arm/Group Description | Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan. fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo total-body irradiation allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation anti-thymocyte globulin: Given IV |
| Measure Participants | 61 |
| Number (95% Confidence Interval) [percentage of participants] |
46.0
74.2%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | |
| Arm/Group Description | Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan. fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo total-body irradiation allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation anti-thymocyte globulin: Given IV | |
All Cause Mortality |
||
| Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | ||
| Affected / at Risk (%) | # Events | |
| Total | 34/62 (54.8%) | |
| Blood and lymphatic system disorders | ||
| Febrile neutropenia | 1/62 (1.6%) | 1 |
| Cardiac disorders | ||
| Atrial tachycardia | 1/62 (1.6%) | 1 |
| Cardiac disorder | 2/62 (3.2%) | 3 |
| Cardio-respiratory arrest | 1/62 (1.6%) | 1 |
| Gastrointestinal disorders | ||
| Abdominal pain | 1/62 (1.6%) | 1 |
| General disorders | ||
| Death | 5/62 (8.1%) | 5 |
| Disease progression | 1/62 (1.6%) | 1 |
| Multi-organ failure | 1/62 (1.6%) | 1 |
| Pain | 1/62 (1.6%) | 1 |
| Pyrexia | 5/62 (8.1%) | 6 |
| Immune system disorders | ||
| Graft versus host disease | 8/62 (12.9%) | 9 |
| Infections and infestations | ||
| Bacteraemia | 2/62 (3.2%) | 2 |
| Cellulitis | 1/62 (1.6%) | 1 |
| Infection | 2/62 (3.2%) | 2 |
| Metabolism and nutrition disorders | ||
| Dehydration | 1/62 (1.6%) | 1 |
| Nervous system disorders | ||
| Cerebral haemorrhage | 1/62 (1.6%) | 1 |
| Headache | 1/62 (1.6%) | 1 |
| Renal and urinary disorders | ||
| Anuria | 1/62 (1.6%) | 1 |
| Haematuria | 2/62 (3.2%) | 3 |
| Renal failure | 2/62 (3.2%) | 3 |
| Urinary tract disorder | 1/62 (1.6%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Lung disorder | 2/62 (3.2%) | 2 |
| Pneumonitis | 1/62 (1.6%) | 1 |
| Respiratory distress | 1/62 (1.6%) | 1 |
| Respiratory failure | 1/62 (1.6%) | 1 |
| Surgical and medical procedures | ||
| Hospitalisation | 12/62 (19.4%) | 16 |
| Vascular disorders | ||
| Hypotension | 2/62 (3.2%) | 2 |
Other (Not Including Serious) Adverse Events |
||
| Treatment (Reduced Intensity Allogeneic Stem Cell Transplant) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/62 (0%) | |
Limitations/Caveats
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 | Senior Administrator, Compliance - Clinical Research Services |
|---|---|
| Organization | Roswell Park Cancer Institute |
| Phone | 716-845-2300 |
- I 118807
- NCI-2009-01508