Acute Lymphocytic Leukemia, Acute Myelogenous Leukemia, Burkitt's Lymphoma, Follicular Lymphoma, Hodgkin Lymphoma, Mantle Cell Lymphoma, Non-Hodgkin Lymphoma
Conditions
Keywords
Haplo identical transplant, Cord blood transplant, Reduced intensity conditioning regimen, Lymphoma, Leukemia
Brief summary
Hematopoietic cell transplants (HCT)are one treatment option for people with leukemia or lymphoma. Family members,unrelated donors or banked umbilical cordblood units with similar tissue type can be used for HCT. This study will compare the effectiveness of two new types of bone marrow transplants in people with leukemia or lymphoma: one that uses bone marrow donated from family members with only partially matched bone marrow; and, one that uses two partially matched cord blood units.
Detailed description
Reduced intensity conditioning (RIC) blood or marrow transplantation (BMT) has allowed older and less clinically fit patients to receive potentially curative treatment with allogeneic HCT for high risk or advanced hematological malignancies. Patients lacking an HLA-matched sibling may receive a graft from a suitably HLA-matched unrelated donor. However, up to a third of patients will not have an HLA-matched sibling or a suitably matched adult unrelated donor (i.e., no more than a mismatch at a single locus). Even when a suitably matched unrelated donor is identified, data from the National Marrow Donor Program (NMDP) indicate that a median of four months is required to complete searches that result in transplantation; thus, some number of patients succumb to their disease while awaiting identification and evaluation of a suitably matched adult unrelated donor. Single or dual center studies have shown that partially HLA-mismatched related bone marrow (haplo-BM) and unrelated double umbilical cord blood (dUCB) are valuable sources of donor cells for RIC HCT, thus extending this treatment modality to patients who lack other donors. In order to study the reproducibility, and thus, the wider applicability of these two alternative donor strategies, The Blood and Marrow Transplantation Clinical Trials Network (BMT CTN) conducted two parallel multicenter prospective Phase II clinical trials. These two studies evaluated the safety and efficacy of related haplo-BM (BMT CTN 0603) and dUCB (BMT CTN 0604) transplantation after RIC. Both of these alternative donor approaches produced early results similar to that reported with unrelated donor, and even HLA-matched sibling, HCT. These data demonstrate not only the efficacy of both of these approaches, but also that both can be safely exported from the single center setting. Both haplo-BM and dUCB grafts can be obtained rapidly for greater than 90% of patients lacking an HLA-matched donor. This study will test the hypothesis that progression free survival at two years after RIC haplo-BM transplantation is similar to the progression free survival after RIC dUCB transplantation.
Interventions
BIOLOGICALHaploidentical Bone Marrow Transplant
The conditioning regimen consists of: Fludarabine (Flu)30 mg/m2 IV Days -6, -5, -4, -3, -2 Cyclophosphamide (Cy) 14.5 mg/kg IV Days -6, -5 Total body irradiation (TBI) 200cGy Day -1 The GVHD prophylaxis regimen consists of: Cy 50 mg/kg IV Days 3, 4 Tacrolimus (IV or PO) beginning Day 5 Mycophenolate mofetil (MMF) 15 mg/kg po three times a day, maximum dose 1 g po TID beginning Day 5 until Day 35
BIOLOGICALDouble Umbilical Cord Blood Transplant
The preparative regimen consists of: Fludarabine 40 mg/m2 IV Days -6, -5, -4,-3, -2 Cyclophosphamide 50 mg/kg IV Day -6 Total Body Irradiation (TBI) 200 cGy Day -1 for patients who have received cytotoxic chemotherapy within the 3 months of enrollment or an autologous transplant within 24 months of enrollment or 300 cGy Day -1 for patients who have not received cytotoxic chemotherapy within the 3 months of enrollment and who have not received an autologous transplant within 24 months of enrollment. The GVHD prophylaxis regimen consists of: Cyclosporine beginning Day -3 with dose adjusted to maintain a trough level of 200-400 ng/mL. Mycophenolate mofetil (MMF) 15 mg/kg po three times a day, maximum dose 1 g po TID beginning Day -3 until Day 35
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Blood and Marrow Transplant Clinical Trials Network
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
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients 18 to 70 years old * Patients must have available both: a)One or more potential related mismatched donors (biologic parent(s) or siblings (full or half) or children). At least low resolution DNA based human leukocyte antigen (HLA) typing at HLA-A, -B, and -DRB1 for potential haploidentical sibling donors is required. b)At least two potential umbilical cord blood units identified. Each unit must have a minimum of 1.5 x 10\^7/kg pre-cryopreserved total nucleated cell dose. For non-red blood cell depleted units, the minimum pre-cryopreserved total nucleated cell dose of each unit must be at least 2.0 x 10\^7/kg. Units must be HLA matched at a minimum of 4/6 to the recipient at HLA-A, HLA-B (at low resolution using DNA based typing) and HLA-DRB1 (at high resolution using DNA based typing). Confirmatory typing is not required for randomization. * Acute Lymphoblastic Leukemia (ALL) in first complete remission (CR1) that is NOT considered favorable-risk as defined by the presence of at least one of the following: Adverse cytogenetics such as t(9;22), t(1;19), t(4;11), other Mixed Lineage Leukemia (MLL) rearrangements; White blood cell counts of greater than 30,000/mcL (B-ALL) or greater than 100,000/mcL (T-ALL)at diagnosis; Recipient age older than 30 years at diagnosis; Time to CR greater than 4 weeks * Acute Myelogeneous Leukemia (AML) in CR1 that is NOT considered as favorable-risk. Favorable risk is defined as having one of the following: t(8.21) without CKIT mutation, inv(16) without CKIT mutation or t(16;16), normal karyotype with mutated NPM1 and not FLT-ITD, normal karyotype with double mutated CEBPA, Acute promyelocytic leukemia (APL) in first molecular remission at end of consolidation * Acute Leukemias in 2nd or subsequent CR * Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR, adult T-cell leukemia/lymphoma in first or subsequent CR * Burkitt's lymphoma: second or subsequent CR * Lymphoma fulfilling the following criteria: Chemotherapy-sensitive (at least stable disease lymphomas that have failed at least 1 prior regimen of multi-agent chemotherapy and are INELIGIBLE for an autologous transplant. Patients with chronic lymphocytic leukemia (CLL) are not eligible regardless of disease status. * Performance status: Karnofsky score greater than or equal to 70%. Additional Patient Inclusion Criteria for Conditioning: * Patients with Adequate Physical Function as Measured by: a. Cardiac: Left ventricular ejection fraction at rest must be greater than or equal to 40%, or shortening fraction less than 25%; b. Hepatic: Bilirubin less than or equal to 2.5 mg/dL, except for patients with Gilbert's syndrome or hemolysis. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and Alkaline Phosphatase less than 5 x upper limit of normal; c. Renal: Serum creatinine within normal range, or if serum creatinine outside normal range, then renal function (measured or estimated creatinine clearance or GFR)greater than 40 mL/min/1.73m\^; d. Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin), forced expiratory volume in one second (FEV1), and forced vital capacity (FVC) greater than 50% predicted; * Additional Patient Inclusion Criteria for Patients Assigned to Haploidentical BM Arm: Patients must be HLA typed at high resolution using DNA based typing at the following HLA-loci: HLA-A, -B, -C and DRB1 and have available a related haploidentical BM donor with 2, 3, or 4 HLA-mismatches. A unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch. The donor and recipient must be HLA identical for at least one antigen (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1. Fulfillment of this criterion shall be considered sufficient evidence that the donor and recipient share one HLA haplotype, and typing of additional family members is not required. * Additional Patient Inclusion Criteria for Patients Assigned to Double Umbilical Cord Blood Arm: 1. Patients must have available two UCB units fulfilling the following criteria: 1. Each unit must have a minimum of 1.5 x 10\^7/kg pre-cryopreserved total nucleated cell dose. For non-red blood cell depleted units, the minimum pre-cryopreserved total nucleated cell dose of each unit must be at least 2.0 x10\^7/kg. 2. Units must be HLA matched at a minimum of 4/6 to the recipient at HLA -A, HLA-B (at low resolution using DNA based typing), and HLA -DRB1 (at high resolution using DNA based typing). 3. Additional graft selection criteria specified in section 2.5 2. Patients must have received at least one cycle of the cytotoxic chemotherapy regimens (or regimen of similar intensity) listed in Appendix D within 3 months of enrollment (measured from the start date of chemotherapy) OR have had an autologous transplant within 24 months of enrollment OR receive 300 cGy as part of the preparative regimen
Exclusion criteria
* Patients with suitably matched related or unrelated donor, as defined per institutional practice. * Recipients of prior autologous hematopoietic stem cell transplantation are ineligible if disease recurrence occurred less than 6 months from their autologous stem cell transplant. * Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings). * Prior allogeneic HCT. * Patients with history of primary idiopathic myelofibrosis or any severe marrow fibrosis. * Planned use of prophylactic donor lymphocyte infusion (DLI) therapy. * Anti-donor HLA antibodies. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Progression Free Survival (PFS) | Year 2 | The primary endpoint is PFS at 2 years post-randomization. Death or disease relapse/progression will be considered as events. The time to event is defined as the time interval from randomization to relapse/progression, to death or to last follow-up, whichever comes first. Relapse is defined by either morphological or cytogenetic evidence of acute leukemia consistent with pre-transplant features, or radiologic evidence of progressive lymphoma. Minimal residual disease will not be considered evidence of relapse, however, minimal residual disease that progresses will be considered as relapse and the date of relapse will be the date of detection of minimal residual disease that prompted an intervention by the treating physician. Finally, institution of any therapy to treat persistent, progressive or relapsed disease, including withdrawal of immunosuppressive therapy or DLI, will be considered evidence of relapse/progression regardless of whether the criteria described above are met. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Neutrophil Recovery | Day 56 | Neutrophil recovery is defined as achieving an absolute neutrophil count greater than or equal to 500/mm\^3 for three consecutive measurements on three different days. The first of the three days will be designated the day of neutrophil recovery. |
| Percentage of Participants With Platelet Recovery | Day 100 | Platelet recovery is defined by two different metrics as the first day of a sustained platelet count greater than 20,000/mm\^3 or greater than 50,000/mm\^3 with no platelet transfusions in the preceding seven days. The first day of the sustained platelet count will be designated the day of platelet engraftment. |
| Participants With Primary Graft Failure | Day 56 | Primary graft failure is defined as less than 5% donor chimerism on all measurements up to and including Day 56. |
| Percentage of Participants With Secondary Graft Failure | Year 2 | Secondary graft failure is defined as initial donor chimerism ≥ 5% declining to \< 5% on subsequent measurements with time to secondary graft failure beginning at the first day of primary engraftment. |
| Percentage of Participants With Acute Graft-versus-Host Disease (aGVHD) | Day 180 | The cumulative incidences of grade II - IV and III - IV acute aGVHD will be determined. |
| Percentage of Participants With Chronic Graft-versus-Host Disease (cGHVD) | Year 2 | The cumulative incidence of cGVHD from the time of transplant will be determined. Data were collected directly from providers and chart review according to the recommendations of the NIH Consensus Conference. |
| Percentage of Participants With PFS by Treatment Arms in Subgroups | Year 2 | Participants' primary diagnosis was categorized into two large groups: leukemia versus lymphoma. Age was dichotomized into two large groups: age \<= 59 versus age \> 59. The Kaplan-Meier estimate for PFS at 2 years post-randomization are provided for each subgroup. |
| Percentage of Participants With Treatment-related Mortality (TRM) | Day 100, Day 180, Year 1, and Year 2 | The cumulative incidence of TRM will be estimated, event for this endpoint is death without evidence of disease progression or recurrence. |
| Percentage of Participants With Relapse/Progression | Year 1, year 2 | Incidence of relapse/progression will be estimated using cumulative incidence function, treating death in remission as a competing risk. Relapse is defined by either morphological or cytogenetic evidence of acute leukemia consistent with pre-transplant features, or radiologic evidence of progressive lymphoma. When in doubt, the diagnosis of recurrent or progressive lymphoma should be documented by tissue biopsy. Minimal residual disease will not be considered evidence of relapse, however, minimal residual disease that progresses will be considered as relapse and the date of relapse will be the date of detection of minimal residual disease that prompted an intervention by the treating physician. Finally, institution of any therapy to treat persistent, progressive or relapsed disease, including withdrawal of immunosuppressive therapy or DLI, will be considered evidence of relapse/progression regardless of whether the criteria described above are met. |
| Toxicities | Day 28, Day 56, Day 180, 1 year, and 2 years | They are all Grade ≥ 3 toxicities based on NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4. |
| Participants With Infections | Up to 2 years | All Grade 2 and 3 infections will be reported. Grade 1 CMV infections through Day 56 will also be reported. |
| Hospital Admission and Length of Stay | Month 6 | Total Time Alive and Not Hospitalized within 6 Months Post Randomization |
| Percentage of Participants With Overall Survival | Year 2 | Overall survival is defined as the time interval between date of randomization and death from any cause or for surviving patients, to last follow-up. The time interval between date of transplant and death from any cause or for surviving patients, to last follow-up are also analyzed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| dUCB Participants will receive double unrelated cord blood transplant using a reduced intensity conditioning regimen.
Double unrelated cord blood Transplant: The conditioning regimen consists of:
* Fludarabine 40 mg/m2 IV Days -6, -5, -4, -3, -2
* Cyclophosphamide 50 mg/kg IV Day -6
* Total Body Irradiation (TBI): - 200 cGy Day -1 for patients who have received cytotoxic chemotherapy within the last 3 months or an autologous transplant within 24 months of enrollment; - 300 cGY Day -1 for patients who have not received cytotoxic chemotherapy within 3 months of enrollment or an autologous transplant within 24 months of enrollment
* Day 0 will be the day of the double UCB transplant
The GVHD prophylaxis regimen consists of:
* Cyclosporine beginning Day -3 with dose adjusted to maintain a trough level of 200-400 ng/mL. Tacrolimus (trough level of 5-15 ng/mL) may be substituted for cyclosporine if the patient is intolerant of cyclosporine or per institutional practice.
* Mycophenolate mofetil (MMF) 15 mg/kg po TID, maximum dose 1 g po TID beginning Day-3 until Day 35
Supportive care includes:
\- Filgrastim (G-CSF) 5 mcg/kg/day beginning Day 1 until ANC \>1500/mm3 for 3 consecutive measurements on at least two different days | 186 |
| Haplo-BM Participants will receive haploidentical bone marrow transplant using a reduced intensity conditioning regimen.
Haploidentical Bone Marrow Transplant: The conditioning regimen consists of:
* Fludarabine (Flu)30 mg/m2 IV Days -6, -5, -4, -3, -2
* Cyclophosphamide (Cy) 14.5 mg/kg IV Days -6, -5
* Total body irradiation (TBI) 200cGy Day -1
* Day 0 will be the day of infusion of non-T-cell depleted bone marrow
The GVHD prophylaxis regimen consists of:
* Cy 50 mg/kg IV Days 3, 4
* Tacrolimus (IV or PO) beginning Day 5 with dose adjusted to maintain a trough level of 5-15 ng/mL. Cyclosporine (trough level of 200-400 ng/mL) may be substituted for tacrolimus if the patient is intolerant of tacrolimus or per institutional practice.
* Mycophenolate mofetil (MMF) 15 mg/kg po three times a day, maximum dose 1 g po TID beginning Day 5 until Day 35
Supportive care includes:
\- Filgrastim (G-CSF) 5 mcg/kg/day beginning Day 5 until ANC \>1500/mm3 for 3 consecutive measurements on at least two different days | 182 |
| Total | 368 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Death | 7 | 10 |
| Overall Study | Protocol Violation | 1 | 11 |
| Overall Study | Transplanted off protocol | 2 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Total | dUCB | Haplo-BM |
|---|---|---|---|
| Age, Continuous Median (Range) | 58.8 years | 58.2 years | 59.9 years |
| CD34+ cell count at infusion | 0.20 cells x 10^6/kg | 0.13 cells x 10^6/kg | 2.87 cells x 10^6/kg |
| CD3+ cell count at infusion | 8.05 cells x 10^6/kg | 5.50 cells x 10^6/kg | 29.66 cells x 10^6/kg |
| CMV Status at Transplant Missing | 1 Participants | 1 Participants | 0 Participants |
| CMV Status at Transplant Negative | 144 Participants | 76 Participants | 68 Participants |
| CMV Status at Transplant Positive | 197 Participants | 98 Participants | 99 Participants |
| Cytogenetics for Leukemia Favorable | 37 Participants | 17 Participants | 20 Participants |
| Cytogenetics for Leukemia Intermediate | 117 Participants | 61 Participants | 56 Participants |
| Cytogenetics for Leukemia Not Available | 30 Participants | 13 Participants | 17 Participants |
| Cytogenetics for Leukemia Poor | 88 Participants | 43 Participants | 45 Participants |
| Disease Risk for Leukemia Patients (N=272) First Complete Remission | 216 Participants | 99 Participants | 117 Participants |
| Disease Risk for Leukemia Patients (N=272) Second Complete Remission | 55 Participants | 35 Participants | 20 Participants |
| Disease Risk for Leukemia Patients (N=272) Third or More | 1 Participants | 0 Participants | 1 Participants |
| Disease Risk for Lymphoma Patients (N=96) Complete Response | 34 Participants | 20 Participants | 14 Participants |
| Disease Risk for Lymphoma Patients (N=96) Follicular or Non-Hodgkin's | 12 Participants | 7 Participants | 5 Participants |
| Disease Risk for Lymphoma Patients (N=96) Partial Response | 50 Participants | 25 Participants | 25 Participants |
| Disease Risk Index High | 72 Participants | 35 Participants | 37 Participants |
| Disease Risk Index Intermediate | 239 Participants | 119 Participants | 120 Participants |
| Disease Risk Index Low | 37 Participants | 23 Participants | 14 Participants |
| Disease Risk Index Not Available | 20 Participants | 9 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants | 22 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 323 Participants | 164 Participants | 159 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| HCT-comorbidity index (CI) 0 | 105 Participants | 52 Participants | 53 Participants |
| HCT-comorbidity index (CI) 1 | 49 Participants | 26 Participants | 23 Participants |
| HCT-comorbidity index (CI) 2 | 49 Participants | 26 Participants | 23 Participants |
| HCT-comorbidity index (CI) >=3 | 139 Participants | 71 Participants | 68 Participants |
| HLA Matching Score for Cord Blood Unit 1 at Enrollment 4/6 | 165 Participants | 83 Participants | 82 Participants |
| HLA Matching Score for Cord Blood Unit 1 at Enrollment 5/6 | 148 Participants | 73 Participants | 75 Participants |
| HLA Matching Score for Cord Blood Unit 1 at Enrollment 6/6 | 55 Participants | 30 Participants | 25 Participants |
| HLA Matching Score for Cord Blood Unit 2 at Enrollment 4/6 | 198 Participants | 99 Participants | 99 Participants |
| HLA Matching Score for Cord Blood Unit 2 at Enrollment 5/6 | 130 Participants | 66 Participants | 64 Participants |
| HLA Matching Score for Cord Blood Unit 2 at Enrollment 6/6 | 40 Participants | 21 Participants | 19 Participants |
| HLA Matching Score for Haploidentical Donor at Randomization 3/6 | 85 Participants | 46 Participants | 39 Participants |
| HLA Matching Score for Haploidentical Donor at Randomization 4/6 | 38 Participants | 22 Participants | 16 Participants |
| HLA Matching Score for Haploidentical Donor at Randomization 4/8 | 1 Participants | 0 Participants | 1 Participants |
| HLA Matching Score for Haploidentical Donor at Randomization 5/8 | 1 Participants | 1 Participants | 0 Participants |
| HLA Matching Score for Haploidentical Donor at Randomization 6/8 | 2 Participants | 1 Participants | 1 Participants |
| HLA Matching Score for Haploidentical Donor at Randomization Not Required* | 241 Participants | 116 Participants | 125 Participants |
| Karnofsky Performance Score <90 | 130 Participants | 59 Participants | 71 Participants |
| Karnofsky Performance Score >=90 | 237 Participants | 126 Participants | 111 Participants |
| Karnofsky Performance Score Missing | 1 Participants | 1 Participants | 0 Participants |
| Number of Regimens Prior to Transplant 0 | 2 Participants | 2 Participants | 0 Participants |
| Number of Regimens Prior to Transplant 1 | 27 Participants | 17 Participants | 10 Participants |
| Number of Regimens Prior to Transplant 2 | 18 Participants | 8 Participants | 10 Participants |
| Number of Regimens Prior to Transplant 3 | 22 Participants | 14 Participants | 8 Participants |
| Number of Regimens Prior to Transplant 4 | 12 Participants | 6 Participants | 6 Participants |
| Number of Regimens Prior to Transplant 5 | 11 Participants | 4 Participants | 7 Participants |
| Number of Regimens Prior to Transplant Unknown | 250 Participants | 124 Participants | 126 Participants |
| Post-thaw CD34+ cell count | 0.20 cells x 10^6/kg | 0.20 cells x 10^6/kg | 0.17 cells x 10^6/kg |
| Post-thaw CD3+ cell count | 6.97 cells x 10^6/kg | 6.97 cells x 10^6/kg | 7.47 cells x 10^6/kg |
| Post-thaw total nucleated cell count | 4.32 cells x 10^7/kg | 4.32 cells x 10^7/kg | 3.12 cells x 10^7/kg |
| Pre-cryopreservation CD34+ cell count | 0.22 cells x 10^6/kg | 0.23 cells x 10^6/kg | 0.21 cells x 10^6/kg |
| Pre-cryopreservation CD3+ cell count | 7.38 cells x 10^6/kg | 7.79 cells x 10^6/kg | 0.00 cells x 10^6/kg |
| Pre-cryopreservation total nucleated cell count | 5.15 cells x 10^7/kg | 5.13 cells x 10^7/kg | 5.59 cells x 10^7/kg |
| Primary Diagnosis Acute Lymphoblastic Leukemia | 63 Participants | 31 Participants | 32 Participants |
| Primary Diagnosis Acute Myelogeneous Leukemia | 196 Participants | 98 Participants | 98 Participants |
| Primary Diagnosis Biphenotypic/Undifferentiated/Prolymphocytic Leukemia | 6 Participants | 1 Participants | 5 Participants |
| Primary Diagnosis Follicular Non-Hodgkin's Lymphoma | 12 Participants | 7 Participants | 5 Participants |
| Primary Diagnosis Hodgkin's Lymphoma | 18 Participants | 10 Participants | 8 Participants |
| Primary Diagnosis Large Cell Lymphoma | 40 Participants | 21 Participants | 19 Participants |
| Primary Diagnosis Mantle Cell Lymphoma | 11 Participants | 6 Participants | 5 Participants |
| Primary Diagnosis Other Lymphoma | 15 Participants | 8 Participants | 7 Participants |
| Primary Diagnosis T-cell Leukemia/Lymphoma | 7 Participants | 4 Participants | 3 Participants |
| Prior Autologous Transplant No Prior Autologous Transplant | 336 Participants | 170 Participants | 166 Participants |
| Prior Autologous Transplant Prior Autologous Transplant | 32 Participants | 16 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 24 Participants | 9 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 61 Participants | 27 Participants | 34 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 271 Participants | 145 Participants | 126 Participants |
| Sex: Female, Male Female | 165 Participants | 89 Participants | 76 Participants |
| Sex: Female, Male Male | 203 Participants | 97 Participants | 106 Participants |
| Time from Diagnosis to Transplant | 233 day | 283 day | 219 day |
| Total nucleated cell count at infusion | 4.46 cells x 10^7/kg | 2.95 cells x 10^7/kg | 26.82 cells x 10^7/kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 97 / 186 | 74 / 182 |
| other Total, other adverse events | 1 / 186 | 0 / 182 |
| serious Total, serious adverse events | 4 / 186 | 9 / 182 |
Outcome results
Primary
Percentage of Participants With Progression Free Survival (PFS)
The primary endpoint is PFS at 2 years post-randomization. Death or disease relapse/progression will be considered as events. The time to event is defined as the time interval from randomization to relapse/progression, to death or to last follow-up, whichever comes first. Relapse is defined by either morphological or cytogenetic evidence of acute leukemia consistent with pre-transplant features, or radiologic evidence of progressive lymphoma. Minimal residual disease will not be considered evidence of relapse, however, minimal residual disease that progresses will be considered as relapse and the date of relapse will be the date of detection of minimal residual disease that prompted an intervention by the treating physician. Finally, institution of any therapy to treat persistent, progressive or relapsed disease, including withdrawal of immunosuppressive therapy or DLI, will be considered evidence of relapse/progression regardless of whether the criteria described above are met.
Time frame: Year 2
Population: The primary endpoint analysis is performed using the intent-to-treat principle so that all randomized patients are included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| dUCB | Percentage of Participants With Progression Free Survival (PFS) | 35.0 percentage of participants |
| Haplo-BM | Percentage of Participants With Progression Free Survival (PFS) | 41.1 percentage of participants |
Comparison: The primary null hypothesis of the study is that there is no difference between the 2 year PFS probabilities for dUCB vs. haplo-BM.p-value: 0.409295% CI: [-5.2, 17.4]Z-test to compare the Kaplan-Meier Est.
Comparison: The null hypothesis of the study is that there is no difference between the 2 year PFS probabilities for dUCB vs. haplo-BM after adjustment for age, performance score, and disease type.p-value: 0.0695% CI: [0.99, 1.7]Regression, Cox
Secondary
Hospital Admission and Length of Stay
Total Time Alive and Not Hospitalized within 6 Months Post Randomization
Time frame: Month 6
Population: The randomized participants are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| dUCB | Hospital Admission and Length of Stay | 127.1 Days | Standard Deviation 48.3 |
| Haplo-BM | Hospital Admission and Length of Stay | 141.2 Days | Standard Deviation 42.5 |
Comparison: The null hypothesis is that there is no difference between the total duration of hospitalization within 6 months post-randomization for dUCB vs. haplo-BM.p-value: 0.0003Wilcoxon (Mann-Whitney)
Secondary
Participants With Infections
All Grade 2 and 3 infections will be reported. Grade 1 CMV infections through Day 56 will also be reported.
Time frame: Up to 2 years
Population: The transplanted participants are included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dUCB | Participants With Infections | # Patients with Infections | 102 Participants |
| dUCB | Participants With Infections | Grade 1 CMV through Day 56 | 94 Participants |
| Haplo-BM | Participants With Infections | # Patients with Infections | 102 Participants |
| Haplo-BM | Participants With Infections | Grade 1 CMV through Day 56 | 84 Participants |
Secondary
Participants With Primary Graft Failure
Primary graft failure is defined as less than 5% donor chimerism on all measurements up to and including Day 56.
Time frame: Day 56
Population: The transplanted participants are included in the analysis. A total of 26 patients (11 on the dUCB arm and 15 on the Haplo-BM arm) who did not proceed to the study transplant are excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| dUCB | Participants With Primary Graft Failure | 13 Participants |
| Haplo-BM | Participants With Primary Graft Failure | 10 Participants |
Secondary
Percentage of Participants With Acute Graft-versus-Host Disease (aGVHD)
The cumulative incidences of grade II - IV and III - IV acute aGVHD will be determined.
Time frame: Day 180
Population: The transplanted participants are included in the analysis. A total of 26 patients (11 on the dUCB arm and 15 on the Haplo-BM arm) who did not proceed to the study transplant are excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dUCB | Percentage of Participants With Acute Graft-versus-Host Disease (aGVHD) | grade II - IV | 34.9 percentage of participants |
| dUCB | Percentage of Participants With Acute Graft-versus-Host Disease (aGVHD) | grade III - IV | 8.6 percentage of participants |
| Haplo-BM | Percentage of Participants With Acute Graft-versus-Host Disease (aGVHD) | grade II - IV | 28.1 percentage of participants |
| Haplo-BM | Percentage of Participants With Acute Graft-versus-Host Disease (aGVHD) | grade III - IV | 7.2 percentage of participants |
Comparison: The null hypothesis is that there is no difference between the aGVHD grade II - IV probabilities post-transplantation for dUCB vs. haplo-BM.p-value: 0.142Gray's test for cumulative Incidence
Comparison: The null hypothesis is that there is no difference between the aGVHD grade III - IV probabilities post-transplantation for dUCB vs. haplo-BM.p-value: 0.604Gray's test for cumulative Incidence
Secondary
Percentage of Participants With Chronic Graft-versus-Host Disease (cGHVD)
The cumulative incidence of cGVHD from the time of transplant will be determined. Data were collected directly from providers and chart review according to the recommendations of the NIH Consensus Conference.
Time frame: Year 2
Population: The transplanted participants are included in the analysis. A total of 26 patients (11 on the dUCB arm and 15 on the Haplo-BM arm) who did not proceed to the study transplant are excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| dUCB | Percentage of Participants With Chronic Graft-versus-Host Disease (cGHVD) | 22.0 percentage of participants |
| Haplo-BM | Percentage of Participants With Chronic Graft-versus-Host Disease (cGHVD) | 26.2 percentage of participants |
Comparison: The null hypothesis is that there is no difference between the cGVHD probabilities post-transplantation for dUCB vs. haplo-BM.p-value: 0.361Gray's test for cumulative Incidence
Secondary
Percentage of Participants With Neutrophil Recovery
Neutrophil recovery is defined as achieving an absolute neutrophil count greater than or equal to 500/mm\^3 for three consecutive measurements on three different days. The first of the three days will be designated the day of neutrophil recovery.
Time frame: Day 56
Population: The transplanted participants are included in the analysis. A total of 26 patients (11 on the dUCB arm and 15 on the Haplo-BM arm) who did not proceed to the study transplant are excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| dUCB | Percentage of Participants With Neutrophil Recovery | 94.9 percentage of participants |
| Haplo-BM | Percentage of Participants With Neutrophil Recovery | 98.8 percentage of participants |
Comparison: The null hypothesis is that there is no difference between the neutrophil engraftment post-transplantation for dUCB vs. haplo-BM.p-value: 0.046Gray's test for cumulative Incidence
Secondary
Percentage of Participants With Overall Survival
Overall survival is defined as the time interval between date of randomization and death from any cause or for surviving patients, to last follow-up. The time interval between date of transplant and death from any cause or for surviving patients, to last follow-up are also analyzed.
Time frame: Year 2
Population: The randomized or transplanted participants are included in the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dUCB | Percentage of Participants With Overall Survival | OS post-randomization | 45.7 percentage of participants |
| dUCB | Percentage of Participants With Overall Survival | OS post-transplant | 46.8 percentage of participants |
| Haplo-BM | Percentage of Participants With Overall Survival | OS post-randomization | 57.0 percentage of participants |
| Haplo-BM | Percentage of Participants With Overall Survival | OS post-transplant | 59.4 percentage of participants |
Comparison: The null hypothesis is that there is no difference between the OS probabilities at year 2 post-randomization for dUCB vs. haplo-BM.p-value: 0.0373Log Rank
Comparison: The null hypothesis is that there is no difference between the OS probabilities at year 2 post-transplant for dUCB vs. haplo-BM.p-value: 0.0235Log Rank
Secondary
Percentage of Participants With PFS by Treatment Arms in Subgroups
Participants' primary diagnosis was categorized into two large groups: leukemia versus lymphoma. Age was dichotomized into two large groups: age \<= 59 versus age \> 59. The Kaplan-Meier estimate for PFS at 2 years post-randomization are provided for each subgroup.
Time frame: Year 2
Population: The randomized participants are included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dUCB | Percentage of Participants With PFS by Treatment Arms in Subgroups | By Primary Disease of Leukemia | 34.8 percentage of participants |
| dUCB | Percentage of Participants With PFS by Treatment Arms in Subgroups | By Primary Disease of Lymphoma | 35.6 percentage of participants |
| dUCB | Percentage of Participants With PFS by Treatment Arms in Subgroups | By Age Group <= 59 years | 37.9 percentage of participants |
| dUCB | Percentage of Participants With PFS by Treatment Arms in Subgroups | By Age Group > 59 years | 31.6 percentage of participants |
| Haplo-BM | Percentage of Participants With PFS by Treatment Arms in Subgroups | By Age Group > 59 years | 42.4 percentage of participants |
| Haplo-BM | Percentage of Participants With PFS by Treatment Arms in Subgroups | By Primary Disease of Leukemia | 41.7 percentage of participants |
| Haplo-BM | Percentage of Participants With PFS by Treatment Arms in Subgroups | By Age Group <= 59 years | 39.6 percentage of participants |
| Haplo-BM | Percentage of Participants With PFS by Treatment Arms in Subgroups | By Primary Disease of Lymphoma | 39.3 percentage of participants |
Secondary
Percentage of Participants With Platelet Recovery
Platelet recovery is defined by two different metrics as the first day of a sustained platelet count greater than 20,000/mm\^3 or greater than 50,000/mm\^3 with no platelet transfusions in the preceding seven days. The first day of the sustained platelet count will be designated the day of platelet engraftment.
Time frame: Day 100
Population: The transplanted participants are included in the analysis. A total of 26 patients (11 on the dUCB arm and 15 on the Haplo-BM arm) who did not proceed to the study transplant are excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dUCB | Percentage of Participants With Platelet Recovery | Platelet recovery to 20K | 86.9 percentage of participants |
| dUCB | Percentage of Participants With Platelet Recovery | Platelet recovery to 50K | 78.3 percentage of participants |
| Haplo-BM | Percentage of Participants With Platelet Recovery | Platelet recovery to 20K | 91.6 percentage of participants |
| Haplo-BM | Percentage of Participants With Platelet Recovery | Platelet recovery to 50K | 84.4 percentage of participants |
Comparison: The null hypothesis is that there is no difference between the platelet engraftment to 20k post-transplantation for dUCB vs. haplo-BM.p-value: 0.16Gray's test for cumulative Incidence
Comparison: The null hypothesis is that there is no difference between the platelet engraftment to 50k post-transplantation for dUCB vs. haplo-BM.p-value: 0.146Gray's test for cumulative Incidence
Secondary
Percentage of Participants With Relapse/Progression
Incidence of relapse/progression will be estimated using cumulative incidence function, treating death in remission as a competing risk. Relapse is defined by either morphological or cytogenetic evidence of acute leukemia consistent with pre-transplant features, or radiologic evidence of progressive lymphoma. When in doubt, the diagnosis of recurrent or progressive lymphoma should be documented by tissue biopsy. Minimal residual disease will not be considered evidence of relapse, however, minimal residual disease that progresses will be considered as relapse and the date of relapse will be the date of detection of minimal residual disease that prompted an intervention by the treating physician. Finally, institution of any therapy to treat persistent, progressive or relapsed disease, including withdrawal of immunosuppressive therapy or DLI, will be considered evidence of relapse/progression regardless of whether the criteria described above are met.
Time frame: Year 1, year 2
Population: The randomized or transplanted participants are included in the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dUCB | Percentage of Participants With Relapse/Progression | 1 Year Post Randomization | 41.1 percentage of participants |
| dUCB | Percentage of Participants With Relapse/Progression | 1 Year Post Transplant | 38.7 percentage of participants |
| dUCB | Percentage of Participants With Relapse/Progression | 2 Year Post Randomization | 47.1 percentage of participants |
| dUCB | Percentage of Participants With Relapse/Progression | 2 Year Post Transplant | 43.5 percentage of participants |
| Haplo-BM | Percentage of Participants With Relapse/Progression | 2 Year Post Transplant | 45.8 percentage of participants |
| Haplo-BM | Percentage of Participants With Relapse/Progression | 1 Year Post Randomization | 37.6 percentage of participants |
| Haplo-BM | Percentage of Participants With Relapse/Progression | 2 Year Post Randomization | 48.4 percentage of participants |
| Haplo-BM | Percentage of Participants With Relapse/Progression | 1 Year Post Transplant | 35.1 percentage of participants |
Comparison: The null hypothesis is that there is no difference between the relapse/progression probabilities post-randomization for dUCB vs. haplo-BM.p-value: 0.968Gray's test for cumulative Incidence
Comparison: The null hypothesis is that there is no difference between the relapse/progression probabilities post- transplantation for dUCB vs. haplo-BM.p-value: 0.907Gray's test for cumulative Incidence
Secondary
Percentage of Participants With Secondary Graft Failure
Secondary graft failure is defined as initial donor chimerism ≥ 5% declining to \< 5% on subsequent measurements with time to secondary graft failure beginning at the first day of primary engraftment.
Time frame: Year 2
Population: The transplanted participants are included in the analysis. A total of 26 patients (11 on the dUCB arm and 15 on the Haplo-BM arm) who did not proceed to the study transplant are excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| dUCB | Percentage of Participants With Secondary Graft Failure | 2.6 percentage of participants |
| Haplo-BM | Percentage of Participants With Secondary Graft Failure | 3.4 percentage of participants |
Comparison: The null hypothesis is that there is no difference between the secondary graft failure probabilities post-transplantation for dUCB vs. haplo-BM.p-value: 0.693Gray's test for cumulative Incidence
Secondary
Percentage of Participants With Treatment-related Mortality (TRM)
The cumulative incidence of TRM will be estimated, event for this endpoint is death without evidence of disease progression or recurrence.
Time frame: Day 100, Day 180, Year 1, and Year 2
Population: The randomized or transplanted participants are included in the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dUCB | Percentage of Participants With Treatment-related Mortality (TRM) | 2 Year Post Transplant | 18.6 percentage of participants |
| dUCB | Percentage of Participants With Treatment-related Mortality (TRM) | Day 100 Post Randomization | 5.5 percentage of participants |
| dUCB | Percentage of Participants With Treatment-related Mortality (TRM) | Day 100 Post Transplant | 6.9 percentage of participants |
| dUCB | Percentage of Participants With Treatment-related Mortality (TRM) | Day 180 Post Randomization | 10.4 percentage of participants |
| dUCB | Percentage of Participants With Treatment-related Mortality (TRM) | Day 180 Post Transplant | 13.1 percentage of participants |
| dUCB | Percentage of Participants With Treatment-related Mortality (TRM) | 1 Year Post Randomization | 14.8 percentage of participants |
| dUCB | Percentage of Participants With Treatment-related Mortality (TRM) | 1 Year Post Transplant | 16.0 percentage of participants |
| dUCB | Percentage of Participants With Treatment-related Mortality (TRM) | 2 Year Post Randomization | 17.9 percentage of participants |
| Haplo-BM | Percentage of Participants With Treatment-related Mortality (TRM) | 2 Year Post Randomization | 10.5 percentage of participants |
| Haplo-BM | Percentage of Participants With Treatment-related Mortality (TRM) | 2 Year Post Transplant | 10.7 percentage of participants |
| Haplo-BM | Percentage of Participants With Treatment-related Mortality (TRM) | Day 180 Post Transplant | 4.8 percentage of participants |
| Haplo-BM | Percentage of Participants With Treatment-related Mortality (TRM) | Day 100 Post Randomization | 3.4 percentage of participants |
| Haplo-BM | Percentage of Participants With Treatment-related Mortality (TRM) | 1 Year Post Transplant | 7.9 percentage of participants |
| Haplo-BM | Percentage of Participants With Treatment-related Mortality (TRM) | Day 100 Post Transplant | 3.6 percentage of participants |
| Haplo-BM | Percentage of Participants With Treatment-related Mortality (TRM) | 1 Year Post Randomization | 6.7 percentage of participants |
| Haplo-BM | Percentage of Participants With Treatment-related Mortality (TRM) | Day 180 Post Randomization | 4.5 percentage of participants |
Comparison: The null hypothesis is that there is no difference between the TRM probabilities post-randomization for dUCB vs. haplo-BM.p-value: 0.039Gray's test for cumulative Incidence
Comparison: The null hypothesis is that there is no difference between the TRM probabilities post-transplantation for dUCB vs. haplo-BMp-value: 0.03Gray's test for cumulative Incidence
Secondary
Toxicities
They are all Grade ≥ 3 toxicities based on NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Time frame: Day 28, Day 56, Day 180, 1 year, and 2 years
Population: The transplanted participants are included in the analysis. A total of 26 patients (11 on the dUCB arm and 15 on the Haplo-BM arm) who did not proceed to the study transplant are excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Thrombotic Thrombocytopenic Purpura | 1 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Cystitis Noninfective | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Acute Kidney Injury | 9 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Infusion Toxicities | 0 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Oral Mucositis | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Cystitis Noninfective | 1 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Acute Kidney Injury | 4 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Chronic Kidney Disease | 0 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Hemorrhage | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Hypotension | 12 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Cardiac Arrhythmia | 6 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Left Ventricular Systolic Dysfunction | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Somnolence | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Thrombotic Thrombocytopenic Purpura | 3 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Capillary Leak Syndrome | 1 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Hypoxia | 9 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Dyspnea | 7 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : ALT | 3 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Oral Mucositis | 3 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : AST | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Bilirubin | 3 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Alkaline Phosphatase | 4 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Abnormal Liver Symptoms | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Received Dialysis | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Seizure | 0 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Acute Kidney Injury | 3 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Chronic Kidney Disease | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Hemorrhage | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Hypotension | 5 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Cardiac Arrhythmia | 3 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Left Ventricular Systolic Dysfunction | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Somnolence | 4 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Thrombotic Thrombocytopenic Purpura | 6 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Capillary Leak Syndrome | 0 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Hypoxia | 6 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Dyspnea | 9 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : ALT | 7 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : AST | 5 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Bilirubin | 3 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Alkaline Phosphatase | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Abnormal Liver Symptoms | 4 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Received Dialysis | 3 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 29-56 : Seizure | 0 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Infusion Toxicities | 0 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Oral Mucositis | 1 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Cystitis Noninfective | 1 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Chronic Kidney Disease | 1 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Hemorrhage | 3 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Hypotension | 12 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Cardiac Arrhythmia | 4 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Left Ventricular Systolic Dysfunction | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Somnolence | 5 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Thrombotic Thrombocytopenic Purpura | 3 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Capillary Leak Syndrome | 1 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Hypoxia | 22 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Dyspnea | 21 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : ALT | 6 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : AST | 8 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Bilirubin | 8 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Alkaline Phosphatase | 4 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Abnormal Liver Symptoms | 6 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Received Dialysis | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 57-180 : Seizure | 0 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Infusion Toxicities | 0 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Oral Mucositis | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Cystitis Noninfective | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Acute Kidney Injury | 4 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Chronic Kidney Disease | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Hemorrhage | 3 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Hypotension | 3 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Cardiac Arrhythmia | 4 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Left Ventricular Systolic Dysfunction | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Somnolence | 3 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Thrombotic Thrombocytopenic Purpura | 4 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Capillary Leak Syndrome | 0 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Hypoxia | 8 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Dyspnea | 10 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : ALT | 4 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : AST | 5 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Bilirubin | 5 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Alkaline Phosphatase | 6 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Abnormal Liver Symptoms | 3 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Received Dialysis | 1 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 181-365 : Seizure | 0 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Infusion Toxicities | 0 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Oral Mucositis | 3 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Cystitis Noninfective | 1 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Acute Kidney Injury | 3 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Chronic Kidney Disease | 1 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Hemorrhage | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Hypotension | 6 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Cardiac Arrhythmia | 0 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Left Ventricular Systolic Dysfunction | 0 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Somnolence | 0 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 0-28 : Infusion Toxicities | 19 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Capillary Leak Syndrome | 0 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Hypoxia | 6 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Received Dialysis | 1 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Dyspnea | 4 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : ALT | 1 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : AST | 0 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Bilirubin | 1 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Alkaline Phosphatase | 1 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Abnormal Liver Symptoms | 2 Toxicities |
| dUCB | Toxicities | Toxicities Reported at Day 363-730 : Seizure | 0 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Infusion Toxicities | 19 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Oral Mucositis | 9 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Cystitis Noninfective | 6 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Acute Kidney Injury | 22 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Chronic Kidney Disease | 5 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Hemorrhage | 12 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Hypotension | 31 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Cardiac Arrhythmia | 14 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Left Ventricular Systolic Dysfunction | 8 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Somnolence | 13 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Thrombotic Thrombocytopenic Purpura | 14 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Capillary Leak Syndrome | 2 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Hypoxia | 41 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Dyspnea | 38 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: ALT | 18 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: AST | 19 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Bilirubin | 18 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Alkaline Phosphatase | 14 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Abnormal Liver Symptoms | 15 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Received Dialysis | 8 Toxicities |
| dUCB | Toxicities | Overall Toxicities Reported Day 0-730: Seizure | 0 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Seizure | 0 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Seizure | 3 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Oral Mucositis | 2 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Chronic Kidney Disease | 9 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Infusion Toxicities | 0 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Thrombotic Thrombocytopenic Purpura | 0 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Infusion Toxicities | 7 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Oral Mucositis | 0 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Oral Mucositis | 2 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Hypoxia | 34 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Cystitis Noninfective | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Cystitis Noninfective | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Acute Kidney Injury | 4 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Capillary Leak Syndrome | 0 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Chronic Kidney Disease | 2 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Acute Kidney Injury | 6 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Hemorrhage | 6 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Hemorrhage | 12 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Hypotension | 10 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Chronic Kidney Disease | 2 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Cardiac Arrhythmia | 6 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Hypoxia | 7 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Left Ventricular Systolic Dysfunction | 0 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Hemorrhage | 5 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Somnolence | 1 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Bilirubin | 13 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Thrombotic Thrombocytopenic Purpura | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Hypotension | 9 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Capillary Leak Syndrome | 0 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Hypotension | 32 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Hypoxia | 9 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Cardiac Arrhythmia | 5 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Dyspnea | 0 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Dyspnea | 8 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : ALT | 6 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Infusion Toxicities | 0 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Left Ventricular Systolic Dysfunction | 0 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Dyspnea | 35 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : AST | 4 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Somnolence | 5 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Bilirubin | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : ALT | 4 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Alkaline Phosphatase | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Thrombotic Thrombocytopenic Purpura | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Abnormal Liver Symptoms | 4 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Cardiac Arrhythmia | 14 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Received Dialysis | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Capillary Leak Syndrome | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 0-28 : Seizure | 0 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Cystitis Noninfective | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : AST | 4 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Acute Kidney Injury | 3 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Hypoxia | 10 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Chronic Kidney Disease | 3 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Abnormal Liver Symptoms | 18 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Hemorrhage | 4 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Dyspnea | 11 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Hypotension | 5 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Bilirubin | 3 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Cardiac Arrhythmia | 2 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : ALT | 4 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Left Ventricular Systolic Dysfunction | 1 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Left Ventricular Systolic Dysfunction | 3 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Somnolence | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : AST | 4 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Thrombotic Thrombocytopenic Purpura | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Alkaline Phosphatase | 3 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Capillary Leak Syndrome | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Bilirubin | 5 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Hypoxia | 5 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: ALT | 19 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Dyspnea | 6 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Alkaline Phosphatase | 4 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : ALT | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Abnormal Liver Symptoms | 5 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : AST | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Abnormal Liver Symptoms | 3 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Bilirubin | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Received Dialysis | 2 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Alkaline Phosphatase | 0 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Received Dialysis | 4 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Abnormal Liver Symptoms | 4 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Somnolence | 13 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Received Dialysis | 2 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 181-365 : Seizure | 2 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 29-56 : Seizure | 0 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Seizure | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Infusion Toxicities | 0 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Infusion Toxicities | 0 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Oral Mucositis | 1 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Alkaline Phosphatase | 12 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Cystitis Noninfective | 2 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Acute Kidney Injury | 7 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Oral Mucositis | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Chronic Kidney Disease | 4 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Infusion Toxicities | 7 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Hemorrhage | 6 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Cystitis Noninfective | 2 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Hypotension | 10 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Thrombotic Thrombocytopenic Purpura | 4 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Cardiac Arrhythmia | 3 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Acute Kidney Injury | 3 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Left Ventricular Systolic Dysfunction | 1 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Oral Mucositis | 6 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Somnolence | 2 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Chronic Kidney Disease | 0 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Thrombotic Thrombocytopenic Purpura | 1 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: AST | 18 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Capillary Leak Syndrome | 0 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Hemorrhage | 0 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Hypoxia | 7 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Cystitis Noninfective | 6 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Dyspnea | 8 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Hypotension | 5 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : ALT | 4 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Capillary Leak Syndrome | 2 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : AST | 5 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Cardiac Arrhythmia | 2 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Bilirubin | 3 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Acute Kidney Injury | 19 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Alkaline Phosphatase | 4 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Left Ventricular Systolic Dysfunction | 1 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Abnormal Liver Symptoms | 5 Toxicities |
| Haplo-BM | Toxicities | Overall Toxicities Reported Day 0-730: Received Dialysis | 9 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 57-180 : Received Dialysis | 2 Toxicities |
| Haplo-BM | Toxicities | Toxicities Reported at Day 363-730 : Somnolence | 4 Toxicities |