Trial Outcomes & Findings for Sirolimus, Tacrolimus, Thymoglobulin and Rituximab as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Haploidentical and HLA Partially Matched Donor Hematopoietic Cell Transplantation (NCT NCT01116232)
NCT ID: NCT01116232
Last Updated: 2019-03-26
Results Overview
TERMINATED
PHASE2
4 participants
During the first six months post transplant
2019-03-26
Participant Flow
Cancer center clinic.
Participant milestones
| Measure |
Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter
Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;
For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).
Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.
peripheral blood stem cell transplantation
sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter
Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;
For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).
Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.
peripheral blood stem cell transplantation
sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow
|
|---|---|
|
Overall Study
Progressive diease
|
4
|
Baseline Characteristics
Sirolimus, Tacrolimus, Thymoglobulin and Rituximab as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Haploidentical and HLA Partially Matched Donor Hematopoietic Cell Transplantation
Baseline characteristics by cohort
| Measure |
Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
n=4 Participants
anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter
Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;
For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).
Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.
peripheral blood stem cell transplantation
sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 2.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the first six months post transplantPopulation: Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: During the first six months post transplantPopulation: Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: During the first six months post transplantPopulation: Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within two years after transplantPopulation: Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At one yearPopulation: Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 100 days of HCTPopulation: Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1 yearPopulation: Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Using flow cytometry at 30, 60, 90, and 180 days post transplant.Population: Study terminated due to lack of funding, no analysis was done for this protocol due to the fact that only four patients were accrued, no data was collected.
Outcome measures
Outcome data not reported
Adverse Events
Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Zaid Al-Kadhimi, M.D.
Barbara Ann Karmanos Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place