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