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

Completed · Phase 2

Conditions studied: Acute Graft Versus Host Disease

In brief

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).

Key facts

Study ID

NCT00803010

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

74

Starts

2008-09-01

Expected to finish

2012-12-01

Last updated by the study team

2015-07-31

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%.

You may not qualify if…

• Those with any Sorror's co-morbidity factors with score > 3
• 2 or more Sorror's factors with composite score of ≥ 3

Where it is running

• H.Lee Moffitt Cancer Center — Tampa, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.