Leukemia, Myelodysplastic-Myeloproliferative Diseases, Myeloproliferative Disorders
Conditions
Brief summary
The study is designed as a Phase III, randomized, open label, multicenter, prospective, comparative trial of granulocyte colony stimulating factor (G-CSF)-mobilized peripheral blood stem cells (PBSC) versus marrow from unrelated donors for transplantation in patients with hematologic malignancies. Recipients will be stratified by transplant center and disease risk and will be randomized to either the PBSC or marrow arm in a 1:1 ratio.
Detailed description
BACKGROUND: Many studies of allogeneic marrow transplantation have shown that a higher dose of marrow cells correlates with more robust hematopoietic engraftment and lower mortality from infectious complications. Peripheral blood stem cells (PBSC) collected after mobilization with granulocyte colony stimulating factor (G-CSF) contain a larger number of CD34-positive (CD34) progenitors and total cells than bone marrow. These observations led to the hypothesis that transplantation of PBSC would lead to lower mortality compared to transplantation of marrow. In addition, PBSC grafts have a higher T cell content, predicting a possibly more powerful anti-leukemia effect. However, the higher T cell content of PBSC may also lead to increased incidence and severity of acute and chronic graft-versus-host disease (GVHD). This concern is especially serious when the donor is unrelated to the recipient. This prospective, randomized, multicenter clinical trial of unrelated donor transplantation will test the hypothesis that transplantation of PBSC leads to similar patient survival compared to transplantation of marrow. DESIGN NARRATIVE: This is a Phase III randomized, open label, multicenter clinical trial sponsored by the National Marrow Donor Program (NMDP) and the National Institutes of Health (NIH). The objective of the trial is to test the null hypothesis that there is no difference in overall survival after PBSC versus marrow transplants from HLA compatible unrelated donors. The study will compare G-CSF-mobilized PBSC transplantation with bone marrow transplantation from HLA-compatible unrelated donors for patients with leukemia, myelodysplastic or myeloproliferative syndromes. Conditioning and GVHD prophylaxis regimens will vary by center and within centers, however, the center must declare before randomization what regimens will be used for each patient. The primary endpoint of this trial is 2-year survival following randomization. Secondary analyses will consider neutrophil and platelet recovery, acute and chronic GVHD, time off all immunosuppressive therapy, relapse, infections, adverse events and immune reconstitution. The trial will include evaluation of patient and donor quality of life, composition of the graft, and immune reconstitution. Accrual is anticipated for 3 years with a follow-up period of 3 years.
Interventions
BIOLOGICALAllogeneic bone marrow transplantation
Bone marrow transplant from HLA compatible unrelated donors.
BIOLOGICALPeripheral blood stem cell transplantation
Peripheral blood transplant from HLA compatible unrelated donors.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Blood and Marrow Transplant Clinical Trials Network
National Cancer Institute (NCI)
National Marrow Donor Program
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 66 Years
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria: One of the following diagnoses: * Acute myelogenous leukemia at the following stages: first remission, second remission, third or subsequent remission, or not in remission * Acute lymphoblastic leukemia at the following stages: first remission, second remission, third or subsequent remission, or not in remission * Chronic myelogenous leukemia at the following stages: chronic phase, accelerated phase, or blast phase * Myelodysplastic syndromes (MDS) at the following stages: refractory anemia; refractory anemia with ringed sideroblasts; refractory cytopenia with multilineage dysplasia; refractory cytopenia with multilineage dysplasia and ringed sideroblasts; refractory anemia with excess blasts-1 (5-10% blasts); refractory anemia with excess blasts-2 (10-20% blasts); myelodysplastic syndrome, unclassified; or MDS associated with isolated del (5q) * Myeloproliferative diseases: chronic myelomonocytic leukemia; agnogenic myeloid metaplasia with myelofibrosis (idiopathic myelofibrosis); juvenile myelomonocytic leukemia * Therapy-related acute myelogenous leukemia (AML) or MDS with prior malignancy that has been in remission for at least 12 months. If the remission is less than 12 months, Medical Monitor or Protocol Chair approval is required for eligibility Patient
Exclusion criteria
* Prior allogeneic or autologous transplants using any hematopoietic stem cell source; patients with secondary malignancies who have had a prior autologous transplant will be eligible; the prior autologous transplant must have been performed for the primary malignancy (such as lymphoma) and must have occurred 12 or more months prior to enrollment * Lymphoma (11% of 2001 NMDP transplants), other malignant disorders (6%), and non-malignant disorders (9%) Donor Inclusion Criteria: * Matched for HLA-A, B, and DRB1 antigens 1. One antigen mismatch at HLA-A, B, or DRB1 is acceptable with or without mismatch at HLA-C 2. Typing is by DNA techniques: intermediate resolution for A, B, and C, and high resolution for DRB1. HLA-C typing is mandatory but will not count in the match. * Willing to undergo both bone marrow harvest and G-CSF administration with apheresis * Willing to be randomly assigned to either marrow or PBSC collection * Adequate peripheral venous access for leukapheresis or willing to undergo placement of a central catheter * Donor center affiliation with NMDP * Additional donor inclusion criteria can be found in the Donor Companion Manual Donor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two-year Overall Survival | Measured at 2 years | Overall survival rate at 2 years according to an intention-to-treat analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Platelet Engraftment | Measured at Day 180 | — |
| Graft Failure | Measured at 28 and 100 days | — |
| Extensive Chronic Graft-versus-host Disease (GVHD) | Measured at 730 days | — |
| Chronic GVHD | Measured at 2 years | — |
| Relapse | Measured at 2 years | Analysis restricted to patients who received the transplant. |
| Infections | Measured at 1 and 2 years | Number of infection reports per patient. |
| Grades III-V Unexpected Adverse Events | Measured by 2 years | — |
| Neutrophil Engraftment | Measured at Day 28 | — |
| Acute GVHD Grade III-IV | 100 days, 180 days | — |
| Current Immunosuppressive (IS) Free Survival | Measured at 2 years | This outcome measure takes into account subsequent immunosuppressive therapy that may occur following discontinuation of initial immunosuppressive therapy. |
| Immune Reconstitution | Measured at 100 days, 6 months, and 1 and 2 years | — |
| Donor Recovery of Baseline Complete Blood Count (CBC) and White Blood Cell Count (WBC) Differential | Measured at 1, 6, and 12 months | — |
| Donor Recovery to Baseline Toxicity Scores | Measured at 1, 6, and 12 months | — |
| Donor Quality of Life | Measured at 1, 6, and 12 months | — |
| Patient Quality of Life | Measured at baseline, 6 months, and 1, 2, and 5 years | — |
| Acute GVHD Grade II-IV | 100 days, 180 days | — |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bone Marrow Bone marrow transplant from HLA compatible unrelated donors | 278 |
| Peripheral-Blood Stem Cells Peripheral blood stem cell transplant from HLA compatible unrelated donors | 273 |
| Total | 551 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not undergo transplantation | 14 | 11 |
Baseline characteristics
| Characteristic | Bone Marrow | Peripheral-Blood Stem Cells | Total |
|---|---|---|---|
| Age, Customized 0-10 years | 9 participants | 9 participants | 18 participants |
| Age, Customized 11-20 years | 26 participants | 11 participants | 37 participants |
| Age, Customized 21-30 years | 42 participants | 45 participants | 87 participants |
| Age, Customized 31-40 years | 42 participants | 49 participants | 91 participants |
| Age, Customized 41-50 years | 52 participants | 55 participants | 107 participants |
| Age, Customized 51-60 years | 69 participants | 75 participants | 144 participants |
| Age, Customized >=61 years | 38 participants | 29 participants | 67 participants |
| Antithymocyte globulin treatment Antithymocyte globulin treatment | 65 participants | 72 participants | 137 participants |
| Antithymocyte globulin treatment No Antithymocyte globulin treatment | 193 participants | 183 participants | 376 participants |
| Antithymocyte globulin treatment Unknown | 20 participants | 18 participants | 38 participants |
| CD34+ cell dose per kilogram (x10^-6) | 2.75 cell dose per kilogram (x10^-6) | 7.70 cell dose per kilogram (x10^-6) | 5.23 cell dose per kilogram (x10^-6) |
| Conditioning regimen Cyclophosphamide and busulfan | 90 participants | 75 participants | 165 participants |
| Conditioning regimen Cyclophosphamide and total-body irradiation | 133 participants | 133 participants | 266 participants |
| Conditioning regimen Fludarabine and melphalan | 16 participants | 25 participants | 41 participants |
| Conditioning regimen Fludarabine, busulfan, and antithymocyte globulin | 39 participants | 40 participants | 79 participants |
| Cytomegalovirus serologic testing Seronegativity for CMV | 121 participants | 138 participants | 259 participants |
| Cytomegalovirus serologic testing Seropositivity for CMV | 142 participants | 123 participants | 265 participants |
| Cytomegalovirus serologic testing Unknown | 15 participants | 12 participants | 27 participants |
| Diagnosis Acute lymphoblastic leukemia | 61 participants | 56 participants | 117 participants |
| Diagnosis Acute myeloid leukemia | 130 participants | 131 participants | 261 participants |
| Diagnosis Chronic myeloid leukemia | 29 participants | 37 participants | 66 participants |
| Diagnosis Chronic myelomonocytic leukemia | 4 participants | 4 participants | 8 participants |
| Diagnosis Myelodysplastic syndrome | 52 participants | 41 participants | 93 participants |
| Diagnosis Myelofibrosis | 2 participants | 4 participants | 6 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 13 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 258 Participants | 244 Participants | 502 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 16 Participants | 26 Participants |
| GVHD prophylaxis Cyclosporine and methotrexate | 67 participants | 59 participants | 126 participants |
| GVHD prophylaxis Other | 28 participants | 18 participants | 46 participants |
| GVHD prophylaxis Tacrolimus and methotrexate | 183 participants | 196 participants | 379 participants |
| Karnofsky performance-status score <90% | 68 participants | 74 participants | 142 participants |
| Karnofsky performance-status score 90-100% | 172 participants | 154 participants | 326 participants |
| Karnofsky performance-status score Unknown | 38 participants | 45 participants | 83 participants |
| Number of donor mismatches at HLA-A, B, C, and DRB1 0 | 200 participants | 209 participants | 409 participants |
| Number of donor mismatches at HLA-A, B, C, and DRB1 1 | 55 participants | 50 participants | 105 participants |
| Number of donor mismatches at HLA-A, B, C, and DRB1 2 | 7 participants | 3 participants | 10 participants |
| Number of donor mismatches at HLA-A, B, C, and DRB1 3 | 2 participants | 0 participants | 2 participants |
| Number of donor mismatches at HLA-A, B, C, and DRB1 Missing | 14 participants | 11 participants | 25 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 10 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 11 Participants | 17 Participants |
| Race (NIH/OMB) White | 250 Participants | 248 Participants | 498 Participants |
| Sex: Female, Male Female | 110 Participants | 127 Participants | 237 Participants |
| Sex: Female, Male Male | 168 Participants | 146 Participants | 314 Participants |
| Transplantation patients Did not undergo transplantation | 14 participants | 11 participants | 25 participants |
| Transplantation patients Underwent transplantation | 264 participants | 262 participants | 526 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 260 | 0 / 261 |
| serious Total, serious adverse events | 13 / 260 | 10 / 261 |
Outcome results
Primary
Two-year Overall Survival
Overall survival rate at 2 years according to an intention-to-treat analysis.
Time frame: Measured at 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bone Marrow | Two-year Overall Survival | 46 percentage of patients |
| Peripheral-Blood Stem Cells | Two-year Overall Survival | 51 percentage of patients |
Secondary
Acute GVHD Grade III-IV
Time frame: 100 days, 180 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bone Marrow | Acute GVHD Grade III-IV | 100 days from transplantation | 13.8 percentage of patients |
| Bone Marrow | Acute GVHD Grade III-IV | 180 days from transplantation | 14.9 percentage of patients |
| Peripheral-Blood Stem Cells | Acute GVHD Grade III-IV | 100 days from transplantation | 16.4 percentage of patients |
| Peripheral-Blood Stem Cells | Acute GVHD Grade III-IV | 180 days from transplantation | 18.8 percentage of patients |
Secondary
Acute GVHD Grade II-IV
Time frame: 100 days, 180 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bone Marrow | Acute GVHD Grade II-IV | 100 days from transplantation | 45.6 percentage of patients |
| Bone Marrow | Acute GVHD Grade II-IV | 180 days from transplantation | 50 percentage of patients |
| Peripheral-Blood Stem Cells | Acute GVHD Grade II-IV | 100 days from transplantation | 46.7 percentage of patients |
| Peripheral-Blood Stem Cells | Acute GVHD Grade II-IV | 180 days from transplantation | 51 percentage of patients |
Secondary
Chronic GVHD
Time frame: Measured at 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bone Marrow | Chronic GVHD | 41 percentage of participants |
| Peripheral-Blood Stem Cells | Chronic GVHD | 53 percentage of participants |
Secondary
Current Immunosuppressive (IS) Free Survival
This outcome measure takes into account subsequent immunosuppressive therapy that may occur following discontinuation of initial immunosuppressive therapy.
Time frame: Measured at 2 years
Population: No data collected.
Secondary
Donor Quality of Life
Time frame: Measured at 1, 6, and 12 months
Population: No data collected
Secondary
Donor Recovery of Baseline Complete Blood Count (CBC) and White Blood Cell Count (WBC) Differential
Time frame: Measured at 1, 6, and 12 months
Population: No data collected
Secondary
Donor Recovery to Baseline Toxicity Scores
Time frame: Measured at 1, 6, and 12 months
Population: No data collected
Secondary
Extensive Chronic Graft-versus-host Disease (GVHD)
Time frame: Measured at 730 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bone Marrow | Extensive Chronic Graft-versus-host Disease (GVHD) | 32 percentage of patients |
| Peripheral-Blood Stem Cells | Extensive Chronic Graft-versus-host Disease (GVHD) | 48 percentage of patients |
Secondary
Grades III-V Unexpected Adverse Events
Time frame: Measured by 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bone Marrow | Grades III-V Unexpected Adverse Events | Elevated LFT S | 0 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Altered mental status | 1 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Blindness | 1 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Confusion | 1 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Intra-abdominal hemorrhage | 1 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Death | 1 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Hypertensive crisis | 0 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Hemolytic transfusion reaction | 0 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Retinal tear | 0 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Pulmonary/dyspnea | 1 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Pericarditis with pericardial effusion | 1 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Myocardial infarction | 1 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Malignancy: skin squamous cell CA | 1 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Acute renal failure | 1 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | R portal vein obstruction | 1 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Right side pulmonary embolus | 1 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Facial trauma - fractured L lamina | 1 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Pulmonary embolism | 1 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Pneumonia | 1 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Vascular: pulmonary embolus | 0 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Sudden death | 0 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Confusion, dehydration, hygroma | 0 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Respiratory decompensation | 0 participants |
| Bone Marrow | Grades III-V Unexpected Adverse Events | Retinopathy both eyes | 0 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Altered mental status | 0 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Malignancy: skin squamous cell CA | 0 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Confusion, dehydration, hygroma | 1 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Blindness | 0 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Acute renal failure | 0 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Confusion | 0 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Retinopathy both eyes | 1 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Intra-abdominal hemorrhage | 0 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | R portal vein obstruction | 0 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Sudden death | 1 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Vascular: pulmonary embolus | 1 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Hypertensive crisis | 1 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Death | 0 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Elevated LFT S | 1 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Right side pulmonary embolus | 1 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Hemolytic transfusion reaction | 1 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Respiratory decompensation | 1 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Pneumonia | 0 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Facial trauma - fractured L lamina | 0 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Pulmonary/dyspnea | 0 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Retinal tear | 1 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Pericarditis with pericardial effusion | 0 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Pulmonary embolism | 1 participants |
| Peripheral-Blood Stem Cells | Grades III-V Unexpected Adverse Events | Myocardial infarction | 1 participants |
Secondary
Graft Failure
Time frame: Measured at 28 and 100 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bone Marrow | Graft Failure | 9 percentage of patients |
| Peripheral-Blood Stem Cells | Graft Failure | 3 percentage of patients |
Secondary
Immune Reconstitution
Time frame: Measured at 100 days, 6 months, and 1 and 2 years
Population: No data collected
Secondary
Infections
Number of infection reports per patient.
Time frame: Measured at 1 and 2 years
Population: Analysis restricted to patients who received the transplant.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bone Marrow | Infections | 0 infections | 49 participants |
| Bone Marrow | Infections | 1 infection | 52 participants |
| Bone Marrow | Infections | 2 infections | 46 participants |
| Bone Marrow | Infections | 3 infections | 30 participants |
| Bone Marrow | Infections | 4 infections | 26 participants |
| Bone Marrow | Infections | 5 infections | 18 participants |
| Bone Marrow | Infections | 6 infections | 11 participants |
| Bone Marrow | Infections | >6 infections | 32 participants |
| Peripheral-Blood Stem Cells | Infections | >6 infections | 30 participants |
| Peripheral-Blood Stem Cells | Infections | 0 infections | 68 participants |
| Peripheral-Blood Stem Cells | Infections | 4 infections | 17 participants |
| Peripheral-Blood Stem Cells | Infections | 1 infection | 50 participants |
| Peripheral-Blood Stem Cells | Infections | 6 infections | 8 participants |
| Peripheral-Blood Stem Cells | Infections | 2 infections | 48 participants |
| Peripheral-Blood Stem Cells | Infections | 5 infections | 16 participants |
| Peripheral-Blood Stem Cells | Infections | 3 infections | 25 participants |
Secondary
Neutrophil Engraftment
Time frame: Measured at Day 28
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bone Marrow | Neutrophil Engraftment | 87 percentage of patients |
| Peripheral-Blood Stem Cells | Neutrophil Engraftment | 97 percentage of patients |
Secondary
Patient Quality of Life
Time frame: Measured at baseline, 6 months, and 1, 2, and 5 years
Population: No data collected
Secondary
Platelet Engraftment
Time frame: Measured at Day 180
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bone Marrow | Platelet Engraftment | Platelet engraftment >20K from time of transplant | 85.8 percentage of patients |
| Bone Marrow | Platelet Engraftment | Platelet engraftment >50K from time of transplant | 80.3 percentage of patients |
| Peripheral-Blood Stem Cells | Platelet Engraftment | Platelet engraftment >20K from time of transplant | 91.6 percentage of patients |
| Peripheral-Blood Stem Cells | Platelet Engraftment | Platelet engraftment >50K from time of transplant | 86.7 percentage of patients |
Secondary
Relapse
Analysis restricted to patients who received the transplant.
Time frame: Measured at 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bone Marrow | Relapse | 28.9 percentage of patients |
| Peripheral-Blood Stem Cells | Relapse | 27.5 percentage of patients |