Trial Outcomes & Findings for Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer (NCT NCT01044745)
NCT ID: NCT01044745
Last Updated: 2023-09-06
Results Overview
Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
At day 100
Results posted on
2023-09-06
Participant Flow
Participant milestones
| Measure |
Treatment (Rituximab and Allogeneic HCT Transplant)
CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.
TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.
laboratory biomarker analysis: Correlative studies
graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy
cyclophosphamide: Given PO or IV
fludarabine phosphate: Given IV
busulfan: Given IV
total-body irradiation: Undergo TBI
graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy
immunosuppressive therapy: Undergo immunosuppressive therapy
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Rituximab and Allogeneic HCT Transplant)
CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.
TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.
laboratory biomarker analysis: Correlative studies
graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy
cyclophosphamide: Given PO or IV
fludarabine phosphate: Given IV
busulfan: Given IV
total-body irradiation: Undergo TBI
graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy
immunosuppressive therapy: Undergo immunosuppressive therapy
|
|---|---|
|
Overall Study
Ineiligible
|
2
|
Baseline Characteristics
Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Rituximab and Allogeneic HCT Transplant)
n=20 Participants
CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.
TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.
laboratory biomarker analysis: Correlative studies
graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy
cyclophosphamide: Given PO or IV
fludarabine phosphate: Given IV
busulfan: Given IV
total-body irradiation: Undergo TBI
graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy
immunosuppressive therapy: Undergo immunosuppressive therapy
|
|---|---|
|
Age, Continuous
|
39 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At day 100Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria.
Outcome measures
| Measure |
Treatment (Rituximab and Allogeneic HCT Transplant)
n=20 Participants
CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.
TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.
laboratory biomarker analysis: Correlative studies
graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy
cyclophosphamide: Given PO or IV
fludarabine phosphate: Given IV
busulfan: Given IV
total-body irradiation: Undergo TBI
graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy
immunosuppressive therapy: Undergo immunosuppressive therapy
|
|---|---|
|
Number of Participants With Grades II-IV Acute GVHD
|
16 Participants
|
SECONDARY outcome
Timeframe: From the date of transplant with relapse/progression or death as censored events, up to 2 yearsEstimated using Kaplan-Meier estimator.
Outcome measures
| Measure |
Treatment (Rituximab and Allogeneic HCT Transplant)
n=18 Participants
CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.
TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.
laboratory biomarker analysis: Correlative studies
graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy
cyclophosphamide: Given PO or IV
fludarabine phosphate: Given IV
busulfan: Given IV
total-body irradiation: Undergo TBI
graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy
immunosuppressive therapy: Undergo immunosuppressive therapy
|
|---|---|
|
Event-free Survival
|
12 months
Interval 6.0 to 18.0
|
SECONDARY outcome
Timeframe: From the date of transplant with death from any cause as a censored event, up to 2 yearsEstimated using Kaplan-Meier estimator.
Outcome measures
| Measure |
Treatment (Rituximab and Allogeneic HCT Transplant)
n=18 Participants
CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.
TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.
laboratory biomarker analysis: Correlative studies
graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy
cyclophosphamide: Given PO or IV
fludarabine phosphate: Given IV
busulfan: Given IV
total-body irradiation: Undergo TBI
graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy
immunosuppressive therapy: Undergo immunosuppressive therapy
|
|---|---|
|
Overall Survival
|
12 months
Interval 9.0 to 18.0
|
SECONDARY outcome
Timeframe: At day 100Transplant-related mortality (TRM) defined as any mortality after transplantation except mortality from relapsed disease - Reported as a simple percentage.
Outcome measures
| Measure |
Treatment (Rituximab and Allogeneic HCT Transplant)
n=18 Participants
CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.
TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.
laboratory biomarker analysis: Correlative studies
graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy
cyclophosphamide: Given PO or IV
fludarabine phosphate: Given IV
busulfan: Given IV
total-body irradiation: Undergo TBI
graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy
immunosuppressive therapy: Undergo immunosuppressive therapy
|
|---|---|
|
Transplant-related Mortality (TRM)
|
0 Participants
|
Adverse Events
Treatment (Rituximab and Allogeneic HCT Transplant)
Serious events: 10 serious events
Other events: 16 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Treatment (Rituximab and Allogeneic HCT Transplant)
n=20 participants at risk
CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.
TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.
laboratory biomarker analysis: Correlative studies
graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy
cyclophosphamide: Given PO or IV
fludarabine phosphate: Given IV
busulfan: Given IV
total-body irradiation: Undergo TBI
graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy
immunosuppressive therapy: Undergo immunosuppressive therapy
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
15.0%
3/20 • Number of events 3
|
|
Gastrointestinal disorders
vomiting
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
anorexia
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
pneumonitis
|
15.0%
3/20 • Number of events 3
|
|
Infections and infestations
sepsis
|
15.0%
3/20 • Number of events 3
|
|
Renal and urinary disorders
acute kidney injury
|
15.0%
3/20 • Number of events 3
|
|
Gastrointestinal disorders
mucositis oral
|
5.0%
1/20 • Number of events 1
|
|
Immune system disorders
Immune system disorders-other
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
ileus
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
dehydration
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
urinary tract infection
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
cystitis
|
15.0%
3/20 • Number of events 3
|
|
Renal and urinary disorders
hematuria
|
5.0%
1/20 • Number of events 1
|
|
Hepatobiliary disorders
thrombotic event
|
5.0%
1/20 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Rituximab and Allogeneic HCT Transplant)
n=20 participants at risk
CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.
TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0.
laboratory biomarker analysis: Correlative studies
graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy
cyclophosphamide: Given PO or IV
fludarabine phosphate: Given IV
busulfan: Given IV
total-body irradiation: Undergo TBI
graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy
immunosuppressive therapy: Undergo immunosuppressive therapy
|
|---|---|
|
Metabolism and nutrition disorders
Hypokalemia
|
35.0%
7/20 • Number of events 15
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
5/20 • Number of events 6
|
|
Infections and infestations
Rash
|
10.0%
2/20 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.0%
8/20 • Number of events 14
|
|
Investigations
creatinine increased
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Infection and infestation - Other
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Sepsis
|
25.0%
5/20 • Number of events 8
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
15.0%
3/20 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Skin infection
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
sinusitis
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
4/20 • Number of events 6
|
|
Infections and infestations
Lung infection
|
10.0%
2/20 • Number of events 2
|
|
Investigations
Weight loss
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
dehydration
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
15.0%
3/20 • Number of events 3
|
|
Gastrointestinal disorders
Mucositis - oral
|
15.0%
3/20 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
4/20 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
2/20 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
5.0%
1/20 • Number of events 1
|
|
Immune system disorders
Immune-system disorders- Other
|
10.0%
2/20 • Number of events 3
|
|
Investigations
blood bilirubin increased
|
10.0%
2/20 • Number of events 2
|
|
Investigations
Alanin amintransferase increased
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Aspartate aminotransferase
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Altered mental status
|
5.0%
1/20 • Number of events 1
|
Additional Information
R. Gregory Bociek, MD
University of Nebraska Medical Center
Phone: 402-559-5388
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place