Lymphoma, B-Cell, Lymphoma, Large-Cell, Immunoblastic, Lymphoma, Non-Hodgkin
Conditions
Keywords
Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma
Brief summary
This study is designed as a Phase III, multicenter trial, comparing progression-free survival (PFS) after autologous hematopoietic stem cell transplantation using a standard Rituxan plus BEAM transplant regimen versus a regimen adding Bexxar to BEAM.
Detailed description
BACKGROUND: Bexxar (Tositumomab and Iodine I 131 Tositumomab) is a radioimmunoconjugate with demonstrated anti-lymphoma effects. This drug is indicated for the treatment of patients with CD20 positive, relapsed or refractory, low grade, follicular, or transformed non-Hodgkin's lymphoma, including patients with Rituximab-refractory non-Hodgkin's lymphoma. Bexxar has been used in several Phase I and II transplant trials either alone or in combination with high-dose chemotherapy for the treatment of relapsed non-Hodgkin's lymphoma. The Phase I and II trials combining Bexxar with BEAM and autologous hematopoietic stem cell transplantation demonstrated promising early results with 80% event-free survival in relapsed chemosensitive diffuse large B-cell non-Hodgkin's lymphoma patients. The administration of Rituxan to the mobilization and conditioning regimen is now the standard of care at most transplant centers. Therefore, the primary endpoint of this study will be to compare progression-free survival after autologous hematopoietic stem cell transplantation for chemotherapy-sensitive diffuse large B-cell lymphoma using Rituxan/BEAM versus Bexxar/BEAM for pre-transplant conditioning. DESIGN NARRATIVE: All patients will receive induction or salvage chemotherapy as indicated by their clinical circumstance to achieve at least a partial response (as defined in the protocol). There must be 20% or less bone marrow involvement after their most recent salvage therapy. Mobilization therapy may be employed per institutional guidelines, but all patients must receive one dose of rituxan (375 mg/m\^2) at least within 4 weeks of actual stem cell apheresis. Patients must have an adequate autograft (target of at least 2.0 X 10\^6 CD34+ cells/kg; minimum of more than 1.5 X 106 CD34+ cells/kg) to be eligible for the protocol. Eligible patients will be randomized to receive either: 1) Rituxan plus BEAM, with Rituxan 375 mg/m\^2 IV Days -19 and -12, Carmustine (BCNU) 300 mg/m\^2 Day -6, Etoposide 100 mg/m\^2 Days -5 to -2, Cytarabine 100 mg/m\^2 Days -5 to -2, and Melphalan 140 mg/m\^2 Day -1 followed by ASCT; or, 2) Bexxar/BEAM with the dosimetric dose of 5 mCi Bexxar on Day -19 and the therapeutic dose calculated to administer 75 cGy total body dose (TBD) on Day -12. Patients will then receive BCNU 300 mg/m\^2 Day -6, Etoposide 100 mg/m\^2 Days -5 to -2, Cytarabine 100 mg/m\^2 Days -5 to -2, and Melphalan 140 mg/m\^2 Day -1 followed by ASCT. Patients will be followed for 2 years post-transplant. Survival data, hematopoiesis data, incidence of infection, mucositis assessment data, immune reconstitution data, and toxicity data will be recorded and reported periodically to the BMT CTN Data Coordinating Center (DCC).
Interventions
DRUGAutologous transplantation using rituxan/BEAM
Rituxan 375 mg/m2 (Day -19 and Day -12); BCNU 300 mg/m2 (Day -6); Etoposide (VP-16) 100 mg/m2 twice a day (Days -5 to -2); Cytarabine 100 mg/m2 twice a day (Days -5 to -2); Melphalan 140 mg/m2 (Day -1); Followed by autologous transplantation
DRUGAutologous transplantation using Bexxar/BEAM
Bexxar dosimetric dose 5 mCi (Day -19); Bexxar therapy dose 75 cGy TBD (Day -12); BCNU 300 mg/m2 (Day -6); Etoposide (VP-16) 100 mg/m2 twice a day (Days -5 to -2); Cytarabine 100 mg/m2 twice a day (Days -5 to -2); Melphalan 140 mg/m2 (Day -1); Followed by autologous transplantation
Sponsors
Blood and Marrow Transplant Clinical Trials Network
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of persistent or recurrent REAL classification diffuse large B-cell lymphoma, composite lymphoma with more than 50% diffuse large B-cell lymphoma, mediastinal B-cell lymphoma * Demonstration of CD20+ on at least one histologic specimen * 18-80 years old at time of first registration * Three or fewer prior regimens of chemotherapy over the entire course of their disease treatment (including one induction chemotherapy and no more than 2 salvage chemotherapies); monoclonal antibody therapy and involved field radiation therapy will not be counted as prior therapies * Disease status of primary induction failure, first relapse, or second complete remission; all patients must have chemosensitive disease as demonstrated by response to induction or salvage chemotherapy with at least a partial response (as defined in the protocol) * No more than a 20% bone marrow involvement * Patients with adequate organ function as measured by: * Cardiac: American Heart Association Class I: Patients with cardiac disease but without resulting limitation of physical activity; ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain; additionally, patients greater than 60 years of age must have a left ventricular ejection fraction at rest of at least 40% demonstrated by Multi-Gated Acquisition Scan (MUGA) * Hepatic: Bilirubin less than 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome) and alanine transaminase (ALT) and aspartate transaminase (AST) less than 3x the upper limit of normal * Renal: Creatinine less than 2.0 mg/dL or creatinine clearance (calculated creatinine clearance is permitted) more than 40 mL/min; no hydronephrosis on CT scan prior to mobilization * Pulmonary: Carbon Monoxide Diffusing Capacity (DLCO), Volume forcibly exhaled in one second (FEV1), forced vital capacity (FVC) at least 45% of predicted (corrected for hemoglobin) * Autologous graft with a minimum of at least 1.5 X 10\^6 CD34+ cells/kg (target greater than 2.0 X 10\^6 CD34+ cells/kg. Peripheral blood stem cells (PBSC) are preferred; however, if PBSC mobilization fails, cells can be obtained by institutional practices (in cases where bone marrow will be used for transplantation, the required CD34+ dose does not apply and institutional practice for total nucleated cell dose should be used). * Initiate conditioning therapy within 3 months of mobilization * Signed informed consent
Exclusion criteria
* Karnofsky performance score less than 70% * Transformed follicular lymphoma * Uncontrolled bacterial, viral, or fungal infection (currently taking medication and with progression or no clinical improvement) * Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Medical Monitor or Protocol Chair; cancer treated with curative intent less than 5 years previously will be allowed * Pregnant (positive β-HCG) or breastfeeding; this patient population is excluded due to the lack of data on the use of Bexxar in patients who are pregnant or breastfeeding * Seropositivity for HIV; this patient population is excluded due to the lack of data on the use of Bexxar in HIV positive patients and because the treatment regimens are too immunosuppressive for this patient population * Fertile men or women unwilling to use contraceptive techniques from the time of initiation of mobilization until six-months post-transplant * Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT) * Patients with evidence of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) or abnormal cytogenetic analysis indicative of MDS on the pre-transplant bone marrow examination * Patients with a prior severe reaction to Rituxan or Filgrastim (G-CSF). Patients with severe reactions to G-CSF that receive pre-medication for control of the reaction are not excluded from study. * Patients who have received prior radioimmunotherapy * Patients with known hypersensitivity to murine proteins
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | 1 and 2 years | Patients are considered a failure for this endpoint if they die, relapse/progress, or receive anti-lymphoma therapy, other than post-transplant consolidative localized radiation (maximum 3 sites) to sites of prior bulk disease pre-transplant (\> 3cm). The time to this event is the time from randomization until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up, whichever comes first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Relapse/Progression | 1 and 2 years | The time to this event is measured from randomization. Deaths without relapse/progression are considered as a competing risk. Surviving patients with no history of relapse/progression are censored at time of last follow-up. |
| Complete Response (CR) and Partial Response (PR) Proportion | Day 100 and 2 years | — |
| Platelet Recovery to 20,000 Cells/μL | 100 and 180 days | — |
| Hematologic Function | 100 days, 1 year | Hematologic function will be defined as ANC \> 1,500 neutrophils/μL, hemoglobin \> 10 g/dL without transfusion support, and platelet count \> 100,000/μL without transfusion support. |
| Incidence of Infection | 1 year | — |
| Overall Survival | 1 and 2 years | The event is death from any cause. The time to this event is the time from randomization to death or last follow-up. Surviving patients are censored at the time of last observation |
| Immune Reconstitution | 1 year | Tests to be performed on peripheral blood include CD2, CD3, CD4, CD8, CD19, CD3+/CD25+, CD45 RA/RO, CD56+/CD3-. |
| Immune Reconstitution of Quantitative Immunoglobulins | 1 year | Tests to be performed on peripheral blood for quantitative immunoglobulins include IgM, IgG and IgA. |
| Treatment-related Mortality (TRM) | 1 and 2 years | TRM is defined as death occurring in a patient from causes other than relapse or progression |
| Neutrophil Recovery | Day 28 and Day 60 | Time to neutrophil recovery will be the first of two consecutive days of \> 500 neutrophils/μL following the expected nadir. |
| Mucositis Severity | Day 21 | Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 equals severe mucosa. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| B-BEAM Bexxar/BEAM | 111 |
| R-BEAM Rituxan/BEAM | 113 |
| Total | 224 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Ineligible Pathology | 1 | 1 |
| Overall Study | Progressive Disease | 6 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | B-BEAM | R-BEAM | Total |
|---|---|---|---|
| Age, Continuous | 55.1 years STANDARD_DEVIATION 13.5 | 56.8 years STANDARD_DEVIATION 12.5 | 56.0 years STANDARD_DEVIATION 13 |
| Disease Status at Transplantation First Partial Response | 21 participants | 15 participants | 36 participants |
| Disease Status at Transplantation First Relapse | 35 participants | 45 participants | 80 participants |
| Disease Status at Transplantation Second Complete Remission | 55 participants | 53 participants | 108 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 9 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 101 Participants | 200 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 3 Participants | 13 Participants |
| Karnofsky Performance-status Score 100% | 29 participants | 26 participants | 55 participants |
| Karnofsky Performance-status Score 70% | 3 participants | 5 participants | 8 participants |
| Karnofsky Performance-status Score 80% | 12 participants | 19 participants | 31 participants |
| Karnofsky Performance-status Score 90% | 67 participants | 63 participants | 130 participants |
| Number of Prior Therapies 1 | 2 participants | 7 participants | 9 participants |
| Number of Prior Therapies 2 | 93 participants | 83 participants | 176 participants |
| Number of Prior Therapies 3 | 16 participants | 23 participants | 39 participants |
| Primary Disease Stage First Relapse | 35 participants | 46 participants | 81 participants |
| Primary Disease Stage Primary Induction Failure | 21 participants | 15 participants | 36 participants |
| Primary Disease Stage Second Complete Remission | 55 participants | 52 participants | 107 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 99 Participants | 103 Participants | 202 Participants |
| Sex: Female, Male Female | 43 Participants | 39 Participants | 82 Participants |
| Sex: Female, Male Male | 68 Participants | 74 Participants | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 111 | 0 / 113 |
| serious Total, serious adverse events | 11 / 111 | 6 / 113 |
Outcome results
Primary
Progression-free Survival (PFS)
Patients are considered a failure for this endpoint if they die, relapse/progress, or receive anti-lymphoma therapy, other than post-transplant consolidative localized radiation (maximum 3 sites) to sites of prior bulk disease pre-transplant (\> 3cm). The time to this event is the time from randomization until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up, whichever comes first.
Time frame: 1 and 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B-BEAM | Progression-free Survival (PFS) | 1 year | 53.2 percentage of participants |
| B-BEAM | Progression-free Survival (PFS) | 2 years | 48.6 percentage of participants |
| R-BEAM | Progression-free Survival (PFS) | 1 year | 56.6 percentage of participants |
| R-BEAM | Progression-free Survival (PFS) | 2 years | 49.0 percentage of participants |
Secondary
Complete Response (CR) and Partial Response (PR) Proportion
Time frame: Day 100 and 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B-BEAM | Complete Response (CR) and Partial Response (PR) Proportion | Day 100 | 69.9 percentage of participants |
| B-BEAM | Complete Response (CR) and Partial Response (PR) Proportion | 2 years | 48.5 percentage of participants |
| R-BEAM | Complete Response (CR) and Partial Response (PR) Proportion | Day 100 | 71.0 percentage of participants |
| R-BEAM | Complete Response (CR) and Partial Response (PR) Proportion | 2 years | 43.9 percentage of participants |
Secondary
Hematologic Function
Hematologic function will be defined as ANC \> 1,500 neutrophils/μL, hemoglobin \> 10 g/dL without transfusion support, and platelet count \> 100,000/μL without transfusion support.
Time frame: 100 days, 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B-BEAM | Hematologic Function | Day 100 | 34.8 percentage of participants |
| B-BEAM | Hematologic Function | 1 year | 64.0 percentage of participants |
| R-BEAM | Hematologic Function | Day 100 | 38.5 percentage of participants |
| R-BEAM | Hematologic Function | 1 year | 58.9 percentage of participants |
Secondary
Immune Reconstitution
Tests to be performed on peripheral blood include CD2, CD3, CD4, CD8, CD19, CD3+/CD25+, CD45 RA/RO, CD56+/CD3-.
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| B-BEAM | Immune Reconstitution | CD3 (cells/uL) | 921.8 cells/uL | Standard Deviation 694.8 |
| B-BEAM | Immune Reconstitution | CD3+/CD25+ (cells/uL) | 112.2 cells/uL | Standard Deviation 92.8 |
| B-BEAM | Immune Reconstitution | CD8 (cells/uL) | 558.5 cells/uL | Standard Deviation 517.9 |
| B-BEAM | Immune Reconstitution | CD45RA (cells/uL) | 469.3 cells/uL | Standard Deviation 404.4 |
| B-BEAM | Immune Reconstitution | CD4 (cells/uL) | 342.8 cells/uL | Standard Deviation 223.9 |
| B-BEAM | Immune Reconstitution | CD56+/CD3- (cells/uL) | 125.1 cells/uL | Standard Deviation 94.6 |
| B-BEAM | Immune Reconstitution | CD19 (cells/uL) | 143.4 cells/uL | Standard Deviation 140.5 |
| B-BEAM | Immune Reconstitution | CD45RO (cells/uL) | 476.2 cells/uL | Standard Deviation 337.4 |
| B-BEAM | Immune Reconstitution | CD2 (cells/uL) | 1006.0 cells/uL | Standard Deviation 767.6 |
| R-BEAM | Immune Reconstitution | CD45RO (cells/uL) | 727.8 cells/uL | Standard Deviation 798.8 |
| R-BEAM | Immune Reconstitution | CD2 (cells/uL) | 1024.9 cells/uL | Standard Deviation 1074.7 |
| R-BEAM | Immune Reconstitution | CD3 (cells/uL) | 990.3 cells/uL | Standard Deviation 1056.1 |
| R-BEAM | Immune Reconstitution | CD4 (cells/uL) | 286.1 cells/uL | Standard Deviation 213.3 |
| R-BEAM | Immune Reconstitution | CD8 (cells/uL) | 697.7 cells/uL | Standard Deviation 901.1 |
| R-BEAM | Immune Reconstitution | CD19 (cells/uL) | 140.8 cells/uL | Standard Deviation 203 |
| R-BEAM | Immune Reconstitution | CD3+/CD25+ (cells/uL) | 118.0 cells/uL | Standard Deviation 127.7 |
| R-BEAM | Immune Reconstitution | CD45RA (cells/uL) | 579.8 cells/uL | Standard Deviation 620.5 |
| R-BEAM | Immune Reconstitution | CD56+/CD3- (cells/uL) | 130.5 cells/uL | Standard Deviation 135.7 |
Secondary
Immune Reconstitution of Quantitative Immunoglobulins
Tests to be performed on peripheral blood for quantitative immunoglobulins include IgM, IgG and IgA.
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| B-BEAM | Immune Reconstitution of Quantitative Immunoglobulins | IgA (mg/dL) | 68.5 mg/dL | Standard Deviation 42.6 |
| B-BEAM | Immune Reconstitution of Quantitative Immunoglobulins | IgG (mg/dL) | 619.6 mg/dL | Standard Deviation 289.2 |
| B-BEAM | Immune Reconstitution of Quantitative Immunoglobulins | IgM (mg/dL) | 51.0 mg/dL | Standard Deviation 36 |
| R-BEAM | Immune Reconstitution of Quantitative Immunoglobulins | IgA (mg/dL) | 85.0 mg/dL | Standard Deviation 71.8 |
| R-BEAM | Immune Reconstitution of Quantitative Immunoglobulins | IgG (mg/dL) | 643.8 mg/dL | Standard Deviation 395.3 |
| R-BEAM | Immune Reconstitution of Quantitative Immunoglobulins | IgM (mg/dL) | 79.0 mg/dL | Standard Deviation 154.4 |
Secondary
Incidence of Infection
Time frame: 1 year
Population: 67 patients treated with B-BEAM incurred a total of 139 infections. 60 patients treated with R-BEAM incurred a total of 121 infections.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B-BEAM | Incidence of Infection | 1 Infection | 38 participants |
| B-BEAM | Incidence of Infection | 2 Infections | 14 participants |
| B-BEAM | Incidence of Infection | 3 Infections | 5 participants |
| B-BEAM | Incidence of Infection | 4 Infections | 3 participants |
| B-BEAM | Incidence of Infection | 5 Infections | 1 participants |
| B-BEAM | Incidence of Infection | 6-10 Infections | 6 participants |
| B-BEAM | Incidence of Infection | >10 Infections | 0 participants |
| R-BEAM | Incidence of Infection | 4 Infections | 4 participants |
| R-BEAM | Incidence of Infection | 1 Infection | 35 participants |
| R-BEAM | Incidence of Infection | >10 Infections | 1 participants |
| R-BEAM | Incidence of Infection | 2 Infections | 11 participants |
| R-BEAM | Incidence of Infection | 6-10 Infections | 2 participants |
| R-BEAM | Incidence of Infection | 3 Infections | 7 participants |
| R-BEAM | Incidence of Infection | 5 Infections | 0 participants |
Secondary
Incidence of Relapse/Progression
The time to this event is measured from randomization. Deaths without relapse/progression are considered as a competing risk. Surviving patients with no history of relapse/progression are censored at time of last follow-up.
Time frame: 1 and 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B-BEAM | Incidence of Relapse/Progression | 1 year | 39.6 percentage of participants |
| B-BEAM | Incidence of Relapse/Progression | 2 years | 44.2 percentage of participants |
| R-BEAM | Incidence of Relapse/Progression | 1 year | 40.7 percentage of participants |
| R-BEAM | Incidence of Relapse/Progression | 2 years | 47.4 percentage of participants |
Secondary
Mucositis Severity
Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 equals severe mucosa.
Time frame: Day 21
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| B-BEAM | Mucositis Severity | 0.72 scores on a scale |
| R-BEAM | Mucositis Severity | 0.31 scores on a scale |
Secondary
Neutrophil Recovery
Time to neutrophil recovery will be the first of two consecutive days of \> 500 neutrophils/μL following the expected nadir.
Time frame: Day 28 and Day 60
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B-BEAM | Neutrophil Recovery | Day 60 | 96.1 percentage of participants |
| B-BEAM | Neutrophil Recovery | Day 28 | 96.1 percentage of participants |
| R-BEAM | Neutrophil Recovery | Day 60 | 95.3 percentage of participants |
| R-BEAM | Neutrophil Recovery | Day 28 | 93.5 percentage of participants |
Secondary
Overall Survival
The event is death from any cause. The time to this event is the time from randomization to death or last follow-up. Surviving patients are censored at the time of last observation
Time frame: 1 and 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B-BEAM | Overall Survival | 1 year | 68.5 percentage of participants |
| B-BEAM | Overall Survival | 2 years | 60.1 percentage of participants |
| R-BEAM | Overall Survival | 1 year | 73.7 percentage of participants |
| R-BEAM | Overall Survival | 2 years | 66.3 percentage of participants |
Secondary
Platelet Recovery to 20,000 Cells/μL
Time frame: 100 and 180 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B-BEAM | Platelet Recovery to 20,000 Cells/μL | Day 100 | 83.5 percentage of participants |
| B-BEAM | Platelet Recovery to 20,000 Cells/μL | Day 180 | 84.5 percentage of participants |
| R-BEAM | Platelet Recovery to 20,000 Cells/μL | Day 100 | 82.2 percentage of participants |
| R-BEAM | Platelet Recovery to 20,000 Cells/μL | Day 180 | 83.2 percentage of participants |
Secondary
Treatment-related Mortality (TRM)
TRM is defined as death occurring in a patient from causes other than relapse or progression
Time frame: 1 and 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B-BEAM | Treatment-related Mortality (TRM) | 1 year | 5.9 percentage of participants |
| B-BEAM | Treatment-related Mortality (TRM) | 2 years | 5.9 percentage of participants |
| R-BEAM | Treatment-related Mortality (TRM) | 1 year | 2.9 percentage of participants |
| R-BEAM | Treatment-related Mortality (TRM) | 2 years | 3.9 percentage of participants |