Status:
COMPLETED
Graft-Versus-Host Disease (GVHD) Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Conditions:
Acute Graft Versus Host Disease
Eligibility:
All Genders
16-70 years
Phase:
PHASE2
Brief Summary
The purpose of this research is to compare the effectiveness of Tacrolimus and Rapamycin to Tacrolimus and Methotrexate in the prevention of severe graft-versus-host-disease. Graft-versus-host-disease...
Detailed Description
All drugs used in this study have been used in the prevention of graft-versus-host-disease after allogeneic hematopoietic cell transplant. Tacrolimus and Methotrexate used in combination are currently...
Eligibility Criteria
Inclusion
- Age ≥ 16 and ≤ 70
- Signed informed consent
- Adequate vital organ function
- No active infection, or asymptomatic infection well controlled by antibiotic HIV negative by ELISA or RT-PCR \[if ELISA is positive and RT-PCR is negative, the ELISA is considered false positive\]
- Hepatitis B and C negative by serology or RT-PCR
- Performance status: Karnofsky Performance Status Score ≥ 60%.
Exclusion
- Those with any Sorror's co-morbidity factors with score \> 3
- 2 or more Sorror's factors with composite score of ≥ 3
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00803010
Start Date
September 1 2008
End Date
December 1 2012
Last Update
July 31 2015
Active Locations (1)
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1
H.Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612