Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Study Details
Study Description
Brief Summary
RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant (UCBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from an unrelated donor, that do not exactly match the patient's blood, 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 make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well donor umbilical cord blood stem cell transplant works in treating patients with hematologic malignancies.
Detailed Description
PRIMARY OBJECTIVES:
- To establish the day +180 overall survival after a myeloablative unrelated double unit UCBT in a single institution setting.
SECONDARY OBJECTIVES:
-
To determine the rates of hematologic and immune reconstitution in patients with high risk hematologic malignancies, who are undergoing myeloablative chemotherapy followed by infusion of double unit UCBT.
-
To determine the contribution of each umbilical cord unit to immune reconstitution with a focus on both initial (day +21 BM, and +28 PB) and sustained engraftment (day +100 BM; PB at +14, +21, +28, +35, +42, +60, +100, +180, +1 and 2 years).
-
To determine the probability of overall survival and disease free survival at one and two years.
-
To describe the incidence of disease recurrence at one and two years in patients post UCBT.
-
To describe the incidence of acute GVHD and chronic GVHD at 100 days and at one year, respectively.
-
To determine the incidence of day 100 and 180 treatment related mortality.
-
To determine the incidence of serious infectious complications in the first year after transplant.
-
To determine the incidence of donor-derived neutrophil and platelet recovery.
-
To determine the incidence of secondary lymphoproliferative diseases following transplantation with umbilical cord blood.
OUTLINE:
PREPARATIVE REGIMEN: Patients receive oral busulfan every 6 hours on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1.
TRANSPLANTATION: Patients undergo double-unit umbilical cord blood allogeneic stem cell transplantation on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally every 8 hours on days -3 to 45. After completion of study treatment, patients are followed periodically.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm I PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Procedure: double-unit umbilical cord blood transplantation
Undergo transplantation
Other: cytogenetic analysis
Correlative studies
Procedure: bone marrow aspiration
Correlative studies
Other: fluorescence in situ hybridization
Correlative studies
Other Names:
Drug: busulfan
Given orally
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: anti-thymocyte globulin
Given IV
Other Names:
Drug: methylprednisolone
Given IV
Other Names:
Drug: cyclosporine
Given IV
Other Names:
Drug: mycophenolate mofetil
Given orally or IV
Other Names:
Other: flow cytometry
Correlative studies
Procedure: allogeneic hematopoietic stem cell transplantation
Undergo transplantation
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [On day +180]
Number of participants alive at 180 days post engraftment.
Secondary Outcome Measures
- Hematologic Engraftment [On day +42]
Number of participants that were able to complete engraftment by day 42.
- Overall Survival [At 1 year]
Number of participants that were alive.
- Overall Survival [At 2 years]
Number of participants that were alive.
- Disease Free [At 1 year]
Number of participants that were disease free
- Disease Free [At 2 years]
Number of participants that were disease free
- Recurrence or Relapse [one year in patients post UCBT]
Number of subjects that had disease recurrence
- Recurrence or Relapse [two years post transplant]
Number of subjects that had disease recurrence
- Transplant Related Mortality [On day 100 post transplant]
Number of subjects that died because of transplant
- Transplant Related Mortality [On day 180 post transplant]
Number of subjects that died because of transplant
- Occurrence of Serious Infections [1 year]
Number of participants that had infections
- Immune Reconstitution [Periodically for 2 years]
Immunodificency panel to see recovery of immune system. Number of participants that recovered.
- Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0 [by day +42]
Number of participants that experienced toxicity related to the transplant
- Incidence of Acute Graft-versus-host Disease (GVHD) [At 100 days]
Number of participants that had acute GVHD
- Incidence of Chronic GVHD [At 1 year]
Number of participants that have chronic GVHD. Chronic GVHD will be diagnosed and graded on clinical and histological criteria from the Center for International Blood and Marrow Transplant Research (CIBMTR)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients will be diagnosed with one of the following hematological malignancies: acute myelogenous leukemia (AML), acute lymphoblastic leukemia, non-Hodgkin's lymphoma, myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), and myeloproliferative and lymphoproliferative disorders
-
AML--First remission (CR1) with high risk features including a known prior diagnosis of myelodysplasia (MDS); therapy related AML; white cell count at presentation > 100,000; presence of extramedullary leukemia at diagnosis; unfavorable AML subtype (M0, M5-M7); poor cytogenetic markers (abnormalities of chromosome 5, 7 or 8, 11q23, Philadelphia chromosome, complex karyotype)
-
AML--Second remission (CR2) or subsequent remission
-
AML--Relapse/Persistent Disease with < 20% bone marrow blasts
-
ALL--First remission (CR1) at high risk for relapse as defined by: B cell ALL white blood cell count (WBC) at presentation > 30,000 (T cell ALL WBC > 100,000); presence of high-risk cytogenetic abnormality such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23), t(8;14)
-
ALL--Second remission (CR2) or subsequent remission
-
ALL--Relapse/Persistent Disease with < 20% bone marrow blasts
-
Non-Hodgkin Lymphoma--Induction failure or relapse and sensitive to most recent chemotherapy
-
MDS--Low or Intermediate-1 International Prognostic Scoring System (IPSS) score with: life-threatening cytopenia(s); and/or red cell or platelet transfusion dependence
-
MDS--ANC < 500, recurrent infections, PRBC transfusions > 2 units/month, poor risk cytogenetics, platelet transfusion dependence
-
MDS--Intermediate-2 or High IPSS score
-
CML--Chronic phase I (CP1) and resistant to or intolerant of tyrosine kinase inhibitors (i.e. imatinib, dasatinib, etc.)
-
CML--CP2 or subsequent chronic phase, including chronic phase achieved after induction therapy for blast crisis
-
Myeloproliferative and lymphoproliferative disorders--eligibility to be determined by a consensus of the physicians on the Case Comprehensive Cancer Center Leukemia/Lymphoma Multidisciplinary Committee
-
Myeloproliferative and lymphoproliferative disorders--must have evidence of disease acceleration to be a candidate for umbilical cord blood transplant; myeloproliferative disorders eligible for transplant include chronic myelomonocytic leukemia (CMML) with high IPSS score and myelofibrosis
-
Myeloproliferative and lymphoproliferative disorders--potential lymphoproliferative disorders eligible for transplant include chronic lymphocytic leukemia, prolymphocytic leukemia, and large granular lymphocytic leukemia
-
Good performance status: Karnofsky >= 70 % or ECOG 0-1
-
Calculated creatinine clearance >= 60 mL/min, or measured creatinine clearance >= 60 mL/min (by 24-hour urine collection) if creatinine >= 1.5 or history of renal dysfunction
-
Hepatic Transaminases < 4 x upper limit normal (ULN); total bilirubin < 2.5 mg/dL, unless the patient has a history of benign congenital hyperbilirubinemia (Gilbert's syndrome)
-
Normal cardiac function by echocardiogram or radionuclide scan, (left ventricular ejection fraction > 45%); if the left ventricular ejection fraction is between 40-50%, clearance by an adult cardiologist is required
-
Pulmonary function tests demonstrating FEV1 > 60% of predicted for age
-
Adults must have a DLCOva > 60% normal
-
For patients unable to complete pulmonary function tests clearance by an adult pulmonologist is required
-
Patients will be eligible for the clinical trial under the following conditions: they do NOT have an HLA-A/B/DR B1 identical RELATED bone marrow donor; they do NOT have a 6/6 HLA-identical matched unrelated adult donor; OR a matched related donor transplant is not in the best interest of the patient (i.e., patient's condition precludes waiting on the donor, too much time to prepare the donor, the donor is ineligible due to medical reasons, or in the case of high risk disease a related donor is not appropriated (syngeneic transplant); the decision must be agreed upon by the consensus of physicians on the Case Comprehensive Cancer Center Leukemia/Lymphoma Multidisciplinary Committee; OR their condition precludes waiting to search and find a donor in the National Marrow Donor Registry
Exclusion Criteria:
-
Female patients who are pregnant or breast-feeding
-
HIV or HTLV-1 positivity
-
Any leukemia with a morphologic relapse or persistent disease in the BM with >= 20% blasts (cytogenetic relapse without morphologic evidence of relapse, or cytogenetic persistent disease is acceptable)
-
Active extramedullary leukemia, including CNS disease
-
Prior hematopoietic stem cell transplant (autologous or allogeneic)
-
Uncontrolled infection
-
Patient has an identical related bone marrow donor or a 6/6 HLA-identical matched unrelated donor
-
Any patient who is unable to provide informed consent or comply with the requirements of the protocol
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | United States | 44106 |
Sponsors and Collaborators
- Case Comprehensive Cancer Center
Investigators
- Principal Investigator: Brenda Cooper, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CASE3Z07
- NCI-2009-01319
- CASE3Z07
Study Results
Participant Flow
Recruitment Details | Participants recruited from medical hospital from 9/2007 thru 2/2013. |
---|---|
Pre-assignment Detail |
Arm/Group Title | Arm I |
---|---|
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Period Title: Overall Study | |
STARTED | 14 |
COMPLETED | 11 |
NOT COMPLETED | 3 |
Baseline Characteristics
Arm/Group Title | Arm I |
---|---|
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Overall Participants | 14 |
Age, Customized (Count of Participants) | |
10-19 yrs |
2
14.3%
|
20-29 yrs |
2
14.3%
|
30-39 yrs |
3
21.4%
|
40-49 yrs |
5
35.7%
|
50-59 yrs |
2
14.3%
|
Sex: Female, Male (Count of Participants) | |
Female |
8
57.1%
|
Male |
6
42.9%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
0
0%
|
Not Hispanic or Latino |
13
92.9%
|
Unknown or Not Reported |
1
7.1%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
3
21.4%
|
White |
11
78.6%
|
More than one race |
0
0%
|
Unknown or Not Reported |
0
0%
|
Region of Enrollment (participants) [Number] | |
United States |
14
100%
|
Outcome Measures
Title | Overall Survival |
---|---|
Description | Number of participants alive at 180 days post engraftment. |
Time Frame | On day +180 |
Outcome Measure Data
Analysis Population Description |
---|
All participants that went on study, whether completing engraftment or not. |
Arm/Group Title | Arm I |
---|---|
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Measure Participants | 14 |
Count of Participants [Participants] |
8
57.1%
|
Title | Hematologic Engraftment |
---|---|
Description | Number of participants that were able to complete engraftment by day 42. |
Time Frame | On day +42 |
Outcome Measure Data
Analysis Population Description |
---|
Participants that went on study. |
Arm/Group Title | Arm I |
---|---|
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Measure Participants | 14 |
Count of Participants [Participants] |
10
71.4%
|
Title | Overall Survival |
---|---|
Description | Number of participants that were alive. |
Time Frame | At 1 year |
Outcome Measure Data
Analysis Population Description |
---|
Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46. |
Arm/Group Title | Arm I |
---|---|
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Measure Participants | 11 |
Count of Participants [Participants] |
6
42.9%
|
Title | Overall Survival |
---|---|
Description | Number of participants that were alive. |
Time Frame | At 2 years |
Outcome Measure Data
Analysis Population Description |
---|
Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46. |
Arm/Group Title | Arm I |
---|---|
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Measure Participants | 11 |
Count of Participants [Participants] |
4
28.6%
|
Title | Disease Free |
---|---|
Description | Number of participants that were disease free |
Time Frame | At 1 year |
Outcome Measure Data
Analysis Population Description |
---|
Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46. |
Arm/Group Title | Arm I |
---|---|
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Measure Participants | 11 |
Count of Participants [Participants] |
4
28.6%
|
Title | Disease Free |
---|---|
Description | Number of participants that were disease free |
Time Frame | At 2 years |
Outcome Measure Data
Analysis Population Description |
---|
Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46. |
Arm/Group Title | Arm I |
---|---|
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Measure Participants | 11 |
Count of Participants [Participants] |
4
28.6%
|
Title | Recurrence or Relapse |
---|---|
Description | Number of subjects that had disease recurrence |
Time Frame | one year in patients post UCBT |
Outcome Measure Data
Analysis Population Description |
---|
Participants that completed engraftment. 10 participants completed engraftment by day 42 and 1 participant completed engraftment by day 46. |
Arm/Group Title | Arm I |
---|---|
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Measure Participants | 11 |
Count of Participants [Participants] |
2
14.3%
|
Title | Recurrence or Relapse |
---|---|
Description | Number of subjects that had disease recurrence |
Time Frame | two years post transplant |
Outcome Measure Data
Analysis Population Description |
---|
Subjects who had completed engraftment |
Arm/Group Title | Arm I |
---|---|
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Measure Participants | 11 |
Count of Participants [Participants] |
2
14.3%
|
Title | Transplant Related Mortality |
---|---|
Description | Number of subjects that died because of transplant |
Time Frame | On day 100 post transplant |
Outcome Measure Data
Analysis Population Description |
---|
Participants that went on study |
Arm/Group Title | Arm I |
---|---|
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Measure Participants | 14 |
Count of Participants [Participants] |
2
14.3%
|
Title | Transplant Related Mortality |
---|---|
Description | Number of subjects that died because of transplant |
Time Frame | On day 180 post transplant |
Outcome Measure Data
Analysis Population Description |
---|
All participants that went on study |
Arm/Group Title | Arm I |
---|---|
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Measure Participants | 14 |
Count of Participants [Participants] |
6
42.9%
|
Title | Occurrence of Serious Infections |
---|---|
Description | Number of participants that had infections |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
All participants that went on study |
Arm/Group Title | Arm I |
---|---|
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Measure Participants | 14 |
Count of Participants [Participants] |
13
92.9%
|
Title | Immune Reconstitution |
---|---|
Description | Immunodificency panel to see recovery of immune system. Number of participants that recovered. |
Time Frame | Periodically for 2 years |
Outcome Measure Data
Analysis Population Description |
---|
Data not collected, panel not done because of funding. |
Arm/Group Title | Arm I |
---|---|
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Measure Participants | 0 |
Title | Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0 |
---|---|
Description | Number of participants that experienced toxicity related to the transplant |
Time Frame | by day +42 |
Outcome Measure Data
Analysis Population Description |
---|
Patients that received transplant |
Arm/Group Title | Arm I |
---|---|
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Measure Participants | 11 |
Count of Participants [Participants] |
8
57.1%
|
Title | Incidence of Acute Graft-versus-host Disease (GVHD) |
---|---|
Description | Number of participants that had acute GVHD |
Time Frame | At 100 days |
Outcome Measure Data
Analysis Population Description |
---|
All participants who went on study |
Arm/Group Title | Arm I |
---|---|
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Measure Participants | 14 |
Count of Participants [Participants] |
11
78.6%
|
Title | Incidence of Chronic GVHD |
---|---|
Description | Number of participants that have chronic GVHD. Chronic GVHD will be diagnosed and graded on clinical and histological criteria from the Center for International Blood and Marrow Transplant Research (CIBMTR) |
Time Frame | At 1 year |
Outcome Measure Data
Analysis Population Description |
---|
All participants that went on study |
Arm/Group Title | Arm I |
---|---|
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Measure Participants | 14 |
Count of Participants [Participants] |
1
7.1%
|
Adverse Events
Time Frame | Adverse Events were collected from participant start on study to going off study up to a period of 2 years. | |
---|---|---|
Adverse Event Reporting Description | Non serious events were not collected. The protocol was assessing efficacy of cord blood in transplants, therefore the research was only gathering SAEs of grade 3 or 4. | |
Arm/Group Title | Arm I | |
Arm/Group Description | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. | |
All Cause Mortality |
||
Arm I | ||
Affected / at Risk (%) | # Events | |
Total | 11/14 (78.6%) | |
Serious Adverse Events |
||
Arm I | ||
Affected / at Risk (%) | # Events | |
Total | 9/14 (64.3%) | |
Blood and lymphatic system disorders | ||
Bone marrow cellularity - Primary graft failure | 1/14 (7.1%) | 1 |
Cardiac disorders | ||
Supraventricular and nodal arrhythmia - Sinus tachycardia | 1/14 (7.1%) | 1 |
Hypotension | 1/14 (7.1%) | 1 |
Gastrointestinal disorders | ||
Diarrhea | 3/14 (21.4%) | 4 |
Colitis, infectious (e.g., Clostridium difficile) | 1/14 (7.1%) | 1 |
General disorders | ||
Death not associated with CTCAE term - Multi-organ failure | 3/14 (21.4%) | 3 |
Death not associated with CTCAE term - Death NOS | 2/14 (14.3%) | 2 |
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | 1/14 (7.1%) | 1 |
Hepatobiliary disorders | ||
Bilirubin (hyperbilirubinemia) | 1/14 (7.1%) | 1 |
Nervous system disorders | ||
Infection with normal ANC or Grade 1 or 2 neutrophils - Brain (encephalitis, infectious) | 1/14 (7.1%) | 1 |
Product Issues | ||
Infection with normal ANC or Grade 1 or 2 neutrophils | 2/14 (14.3%) | 2 |
Respiratory, thoracic and mediastinal disorders | ||
Hemorrhage, pulmonary/upper respiratory - Nose | 1/14 (7.1%) | 1 |
Hypoxia | 4/14 (28.6%) | 5 |
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) | 1/14 (7.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
Arm I | ||
Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) |
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 | Brenda Cooper MD |
---|---|
Organization | Case Comprehensive Cancer Center |
Phone | 216-844-3213 |
brenda.cooper@uhhospitals.org |
- CASE3Z07
- NCI-2009-01319
- CASE3Z07