Trial Outcomes & Findings for Optimized Donor Selection, Nonmyeloablative BMT for B-cell Lymphomas With Post-transplantation Cy and Rituximab (NCT NCT00946023)
NCT ID: NCT00946023
Last Updated: 2018-08-27
Results Overview
Percentage of participants alive and without relapse or disease progression.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
135 participants
Primary outcome timeframe
1 year post-intervention
Results posted on
2018-08-27
Participant Flow
52 participants were screen failures and did not proceed on the study.
Participant milestones
| Measure |
Transplant
Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.
Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily
Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction
Tacrolimus: Start on Day 5 through Day 180
Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
|
|---|---|
|
Overall Study
STARTED
|
83
|
|
Overall Study
COMPLETED
|
83
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimized Donor Selection, Nonmyeloablative BMT for B-cell Lymphomas With Post-transplantation Cy and Rituximab
Baseline characteristics by cohort
| Measure |
Transplant
n=83 Participants
Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.
Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily
Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction
Tacrolimus: Start on Day 5 through Day 180
Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Age, Customized
>= 60 years old
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
83 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year post-interventionPopulation: Populations were analyzed as follows: 1. All participants 2. Recipients of haploidentical donors (69 participants) 3. Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)
Percentage of participants alive and without relapse or disease progression.
Outcome measures
| Measure |
Transplant
n=83 Participants
Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.
Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily
Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction
Tacrolimus: Start on Day 5 through Day 180
Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
|
|---|---|
|
Progression-free Survival
All participants
|
71 percentage of participants
Interval 62.0 to 82.0
|
|
Progression-free Survival
Haploidentical recipients
|
70 percentage of participants
Interval 61.0 to 81.0
|
|
Progression-free Survival
VV donor
|
82 percentage of participants
Interval 66.0 to 100.0
|
|
Progression-free Survival
VF donor
|
70 percentage of participants
Interval 56.0 to 85.0
|
|
Progression-free Survival
FF donor
|
65 percentage of participants
Interval 44.0 to 88.0
|
SECONDARY outcome
Timeframe: 2 years post-interventionPopulation: Populations were analyzed as follows: All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)
Percentage of participants alive with and without relapse.
Outcome measures
| Measure |
Transplant
n=83 Participants
Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.
Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily
Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction
Tacrolimus: Start on Day 5 through Day 180
Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
|
|---|---|
|
Progression-free Survival
All participants
|
60 percentage of participants
Interval 52.0 to 70.0
|
|
Progression-free Survival
Haploidentical recipients
|
63 percentage of participants
Interval 52.0 to 76.0
|
|
Progression-free Survival
VV donor
|
68 percentage of participants
Interval 48.0 to 96.0
|
|
Progression-free Survival
VF donor
|
59 percentage of participants
Interval 46.0 to 76.0
|
|
Progression-free Survival
FF donor
|
56 percentage of participants
Interval 39.0 to 81.0
|
SECONDARY outcome
Timeframe: 1 year post interventionPopulation: Populations were analyzed as follows: All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)
Percentage of participants alive.
Outcome measures
| Measure |
Transplant
n=83 Participants
Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.
Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily
Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction
Tacrolimus: Start on Day 5 through Day 180
Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
|
|---|---|
|
Overall Survival
All participants
|
86 percentage of participants
Interval 78.0 to 93.0
|
|
Overall Survival
Haploidentical recipients
|
83 percentage of participants
Interval 74.0 to 92.0
|
|
Overall Survival
VV donor
|
94 percentage of participants
Interval 84.0 to 100.0
|
|
Overall Survival
VF donor
|
86 percentage of participants
Interval 76.0 to 97.0
|
|
Overall Survival
FF donor
|
78 percentage of participants
Interval 63.0 to 97.0
|
SECONDARY outcome
Timeframe: 2 years post interventionPopulation: Populations were analyzed as follows: All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)
Percentage of participants alive.
Outcome measures
| Measure |
Transplant
n=83 Participants
Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.
Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily
Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction
Tacrolimus: Start on Day 5 through Day 180
Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
|
|---|---|
|
Overall Survival
All participants
|
76 percentage of participants
Interval 67.0 to 86.0
|
|
Overall Survival
Haploidentical recipients
|
73 percentage of participants
Interval 63.0 to 84.0
|
|
Overall Survival
VV donor
|
87 percentage of participants
Interval 71.0 to 100.0
|
|
Overall Survival
VF donor
|
76 percentage of participants
Interval 64.0 to 90.0
|
|
Overall Survival
FF donor
|
69 percentage of participants
Interval 52.0 to 91.0
|
SECONDARY outcome
Timeframe: 1 year post interventionPopulation: Populations were analyzed as follows: All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)
Percentage of participants alive with relapse or disease progression.
Outcome measures
| Measure |
Transplant
n=83 Participants
Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.
Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily
Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction
Tacrolimus: Start on Day 5 through Day 180
Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
|
|---|---|
|
Relapse
All participants
|
20 percentage of participants
Interval 13.0 to 28.0
|
|
Relapse
Haploidentical recipients
|
20 percentage of participants
Interval 11.0 to 30.0
|
|
Relapse
VV donor
|
18 percentage of participants
Interval 0.0 to 36.0
|
|
Relapse
VF donor
|
23 percentage of participants
Interval 10.0 to 36.0
|
|
Relapse
FF donor
|
17 percentage of participants
Interval 1.0 to 33.0
|
SECONDARY outcome
Timeframe: 2 years post interventionPopulation: Populations were analyzed as follows: All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)
Percentage of participants alive with relapse or disease progression.
Outcome measures
| Measure |
Transplant
n=83 Participants
Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.
Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily
Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction
Tacrolimus: Start on Day 5 through Day 180
Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
|
|---|---|
|
Relapse
All participants
|
27 percentage of participants
Interval 17.0 to 37.0
|
|
Relapse
Haploidentical recipients
|
23 percentage of participants
Interval 13.0 to 34.0
|
|
Relapse
VV donor
|
25 percentage of participants
Interval 3.0 to 46.0
|
|
Relapse
VF donor
|
31 percentage of participants
Interval 17.0 to 45.0
|
|
Relapse
FF donor
|
22 percentage of participants
Interval 4.0 to 39.0
|
SECONDARY outcome
Timeframe: 1 year post interventionPercentage of participants who died due to BMT-related reasons.
Outcome measures
| Measure |
Transplant
n=83 Participants
Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.
Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily
Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction
Tacrolimus: Start on Day 5 through Day 180
Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
|
|---|---|
|
Non-relapse Mortality
|
8 percentage of participants
Interval 2.0 to 14.0
|
SECONDARY outcome
Timeframe: 1 year post interventionPercentage of participants who experienced grade II, III, or IV acute GVHD. Acute GVHD is graded using the Przepiorka criteria.
Outcome measures
| Measure |
Transplant
n=83 Participants
Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.
Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily
Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction
Tacrolimus: Start on Day 5 through Day 180
Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
|
|---|---|
|
Incidence of Grades II-IV Acute Graft-versus-Host-Disease (GVHD)
|
41 percentage of participants
Interval 30.0 to 52.0
|
SECONDARY outcome
Timeframe: 1 year post interventionPercentage of participants who experienced grade II, III, or IV acute GVHD. Acute GVHD is graded using the Przepiorka criteria.
Outcome measures
| Measure |
Transplant
n=83 Participants
Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.
Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily
Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction
Tacrolimus: Start on Day 5 through Day 180
Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
|
|---|---|
|
Incidence of Grades III-IV Acute GVHD
|
5 percentage of participants
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: 1 year post interventionPercentage of participants who experienced chronic GVHD. Chronic GVHD is graded using NIH consensus criteria and Seattle criteria.
Outcome measures
| Measure |
Transplant
n=83 Participants
Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.
Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily
Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction
Tacrolimus: Start on Day 5 through Day 180
Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
|
|---|---|
|
Incidence of Chronic GVHD
|
11 percentage of participants
Interval 4.0 to 18.0
|
SECONDARY outcome
Timeframe: Day 60Percentage of patients who engrafted neutrophils and platelets.
Outcome measures
| Measure |
Transplant
n=83 Participants
Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.
Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily
Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction
Tacrolimus: Start on Day 5 through Day 180
Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
|
|---|---|
|
Engraftment
Neutrophil engraftment
|
98 percentage of participants
Interval 94.0 to 100.0
|
|
Engraftment
Platelet engraftment
|
98 percentage of participants
Interval 94.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 60Population: Two participants were not analyzed because they died prior to Day 60.
Percentage of participants who failed to engraft.
Outcome measures
| Measure |
Transplant
n=81 Participants
Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.
Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily
Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction
Tacrolimus: Start on Day 5 through Day 180
Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
|
|---|---|
|
Graft Failure
|
2 Participants
|
Adverse Events
Transplant
Serious events: 56 serious events
Other events: 62 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
Transplant
n=83 participants at risk
Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.
Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily
Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction
Tacrolimus: Start on Day 5 through Day 180
Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.2%
6/83 • Number of events 7 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.6%
3/83 • Number of events 3 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Metabolism and nutrition disorders
Respiratory acidosis
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.4%
2/83 • Number of events 4 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Renal and urinary disorders
Renal failure
|
9.6%
8/83 • Number of events 8 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Immune system disorders
Hemophagocytic syndrome
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Blood and lymphatic system disorders
Deep vein thrombosis
|
4.8%
4/83 • Number of events 4 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Immune system disorders
Allergic reaction
|
3.6%
3/83 • Number of events 3 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
4/83 • Number of events 4 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.6%
3/83 • Number of events 3 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
2/83 • Number of events 2 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
General disorders
Chest pain
|
2.4%
2/83 • Number of events 2 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
1.2%
1/83 • Number of events 2 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Cardiac disorders
Hypotension
|
6.0%
5/83 • Number of events 5 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Cardiac disorders
Tachycardia
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
General disorders
Rigors/chills
|
6.0%
5/83 • Number of events 5 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Gastrointestinal disorders
Dehydration
|
2.4%
2/83 • Number of events 2 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
General disorders
Failure to thrive
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
General disorders
Fever
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.6%
3/83 • Number of events 4 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Cardiac disorders
Volume overload
|
3.6%
3/83 • Number of events 3 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
4/83 • Number of events 4 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Gastrointestinal disorders
Cholelithiasis
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Gastrointestinal disorders
Diarrhea
|
9.6%
8/83 • Number of events 9 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Blood and lymphatic system disorders
Bleeding
|
3.6%
3/83 • Number of events 3 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
2/83 • Number of events 2 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Gastrointestinal disorders
Odynophagia
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.4%
2/83 • Number of events 2 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Gastrointestinal disorders
Colitis
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Hepatobiliary disorders
Liver failure
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Infections and infestations
Infection
|
57.8%
48/83 • Number of events 132 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Investigations
Hyperkalemia
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Investigations
Hypogammaglobulinemia
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Nervous system disorders
Altered consciousness
|
8.4%
7/83 • Number of events 9 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Nervous system disorders
Optic neuritis
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.2%
1/83 • Number of events 1 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
3/83 • Number of events 4 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
Other adverse events
| Measure |
Transplant
n=83 participants at risk
Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.
Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily
Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily
Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction
Tacrolimus: Start on Day 5 through Day 180
Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV
|
|---|---|
|
General disorders
Fever
|
6.0%
5/83 • Number of events 5 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Infections and infestations
Infection
|
55.4%
46/83 • Number of events 86 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Infections and infestations
Neutropenic fever
|
13.3%
11/83 • Number of events 13 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.0%
5/83 • Number of events 7 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Skin and subcutaneous tissue disorders
Rash
|
39.8%
33/83 • Number of events 43 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
6.0%
5/83 • Number of events 5 • 1 year
Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place