Trial Outcomes & Findings for Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis (NCT NCT02065154)
NCT ID: NCT02065154
Last Updated: 2022-09-30
Results Overview
To calculate the percentage of patients developing graft versus host disease, grade II-IV, in the first 100 days after transplant
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Till 100 days post transplant
Results posted on
2022-09-30
Participant Flow
Participant milestones
| Measure |
Cyclophosphamide (Cytoxan)
Cyclophosphamide (Cytoxan)
Cyclophosphamide
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis
Baseline characteristics by cohort
| Measure |
Treatment
n=39 Participants
Cyclophosphamide (Cytoxan)
Cyclophosphamide
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Till 100 days post transplantTo calculate the percentage of patients developing graft versus host disease, grade II-IV, in the first 100 days after transplant
Outcome measures
| Measure |
Treatment
n=39 Participants
Cyclophosphamide (Cytoxan)
Cyclophosphamide
|
|---|---|
|
Grade II-IV Acute GVHD
|
30 percentage of participants
Interval 15.2 to 40.1
|
SECONDARY outcome
Timeframe: 2 Year Post TransplantWhat percentage of participants were alive at a certain time point after transplant
Outcome measures
| Measure |
Treatment
n=39 Participants
Cyclophosphamide (Cytoxan)
Cyclophosphamide
|
|---|---|
|
Overall Survival
|
51 percentage of participants
|
SECONDARY outcome
Timeframe: 1 Year Post-transplantWhat percentage of participants did not have relapse of disease after transplant
Outcome measures
| Measure |
Treatment
n=39 Participants
Cyclophosphamide (Cytoxan)
Cyclophosphamide
|
|---|---|
|
Disease-free Survival
|
46.15 percentage of participants
|
SECONDARY outcome
Timeframe: 100 Days Post TransplantNumber of toxicities experienced by the patients in the study
Outcome measures
| Measure |
Treatment
n=39 Participants
Cyclophosphamide (Cytoxan)
Cyclophosphamide
|
|---|---|
|
Regimen Related Toxicity
|
6 Number of toxicities
|
SECONDARY outcome
Timeframe: 2 years post-transplantWhat percentage of participants relapsed
Outcome measures
| Measure |
Treatment
n=39 Participants
Cyclophosphamide (Cytoxan)
Cyclophosphamide
|
|---|---|
|
Relapse Rate
|
21 percentage of participants
|
Adverse Events
Cytoxan
Serious events: 8 serious events
Other events: 0 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Cytoxan
n=39 participants at risk
Patients getting cytoxan
|
|---|---|
|
Cardiac disorders
Tamponade
|
2.6%
1/39 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
AKI
|
5.1%
2/39 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp distress
|
5.1%
2/39 • Number of events 2 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
2.6%
1/39 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Serious infection
|
5.1%
2/39 • Number of events 2 • 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place