Overview

Graft-Versus-Host Disease (GVHD) Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation

Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
All
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 (GVHD) is a risk associated with allogeneic hematopoietic cell transplants (HCT). An allogeneic hematopoietic cell transplant is a transplant using bone marrow and blood cells that come from someone other than the patient (a donor).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Treatments:
Everolimus
Methotrexate
Sirolimus
Tacrolimus
Criteria
Inclusion Criteria:

- 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 Criteria:

- Those with any Sorror's co-morbidity factors with score > 3

- 2 or more Sorror's factors with composite score of ≥ 3