Trial Outcomes & Findings for Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD (NCT NCT00186628)
NCT ID: NCT00186628
Last Updated: 2017-11-28
Results Overview
The cumulative percentage of participants who develop chronic graft-vs-host disease (cGvHD). Chronic cGvHD was defined as at least one instance of a clinically-accepted marker for cGvHD (see Filipovich, et al. Biology of Blood and Marrow Transplantation. 2005;11:945-955)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
4 years
Results posted on
2017-11-28
Participant Flow
Participant milestones
| Measure |
Prophylactic Rituximab
Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Prophylactic Rituximab
Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by subject (before treatment)
|
1
|
Baseline Characteristics
Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD
Baseline characteristics by cohort
| Measure |
Prophylactic Rituximab
n=36 Participants
Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
|
|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Patient Disease characteristics
CLL- Chronic Lymphocytic Leukemia
|
22 participants
n=5 Participants
|
|
Patient Disease characteristics
MCL- Mantle Cell lymphoma
|
13 participants
n=5 Participants
|
|
Patient Disease characteristics
unknown or Not Reported
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: 35 total participants were analyzed. No data is available for the withdrawn participant.
The cumulative percentage of participants who develop chronic graft-vs-host disease (cGvHD). Chronic cGvHD was defined as at least one instance of a clinically-accepted marker for cGvHD (see Filipovich, et al. Biology of Blood and Marrow Transplantation. 2005;11:945-955)
Outcome measures
| Measure |
Prophylactic Rituximab
n=35 Participants
Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
|
Prophylactic Rituximab (MCL Patients)
MCL participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
|
|---|---|---|
|
Chronic Graft-vs-Host Disease (cGvHD)
|
20 percentage of participants
Interval 6.0 to 34.0
|
—
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: 35 total participants were analyzed. No data is available for the withdrawn participant.
Subjects who Relapsed following after Allogeneic HSCT
Outcome measures
| Measure |
Prophylactic Rituximab
n=35 Participants
Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
|
Prophylactic Rituximab (MCL Patients)
MCL participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
|
|---|---|---|
|
Incidence of Relapse
|
18 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 100 and 1 yearPopulation: 35 total participants were analyzed. No data is available for the withdrawn participant.
Number of participants who died within 100 days and within 1 year, non-relapse and associated with relapse.
Outcome measures
| Measure |
Prophylactic Rituximab
n=35 Participants
Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
|
Prophylactic Rituximab (MCL Patients)
MCL participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
|
|---|---|---|
|
Mortality
Mortality within 100 days, all causes
|
0 Participants
|
—
|
|
Mortality
Nonrelapse mortality within 1 year
|
1 Participants
|
—
|
|
Mortality
Relapse + mortality within 1 year
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: 35 total participants were analyzed. No data is available for the withdrawn participant.
Outcome measures
| Measure |
Prophylactic Rituximab
n=22 Participants
Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
|
Prophylactic Rituximab (MCL Patients)
n=13 Participants
MCL participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
|
|---|---|---|
|
Overall Survival
|
73 Percentage of participants by disease
Interval 57.0 to 94.0
|
69 Percentage of participants by disease
Interval 48.0 to 99.0
|
Adverse Events
Prophylactic Rituximab
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prophylactic Rituximab
n=35 participants at risk
Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
|
|---|---|
|
General disorders
Flu-like symptom - Headache
|
2.9%
1/35 • Number of events 1 • 90 days
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes
|
2.9%
1/35 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Acute Graft vs Host Disease
|
2.9%
1/35 • Number of events 1 • 90 days
|
|
Blood and lymphatic system disorders
Graft vs Host Disease
|
2.9%
1/35 • Number of events 1 • 90 days
|
Other adverse events
| Measure |
Prophylactic Rituximab
n=35 participants at risk
Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab
|
|---|---|
|
General disorders
Flu-like symptoms
|
11.4%
4/35 • Number of events 4 • 90 days
|
Additional Information
David Miklos, MD, PhD; Associate Professor of Medicine (Blood and Marrow Transplantation)
Stanford University Medical Center
Phone: 650-725-4626
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place