Phase 2
N=74
Graft-Versus-Host Disease (GVHD) Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation
Acute Graft Versus Host Disease
Bottom Line
View on ClinicalTrials.gov: NCT00803010 ↗Enrolled (actual)
74
Serious AEs
6.8%
Results posted
May 2014
Primary outcome: Primary: Percentage of Participants With Evidence of Acute Graft Versus Host Disease (aGVHD), Post Transplant — 43; 89 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tacrolimus (TAC) (Drug); Methotrexate (MTX) (Drug); Rapamycin (RAPA) (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Evidence of Acute Graft Versus Host Disease (aGVHD), Post Transplant |
43; 89 | — |
| SECONDARY Incidence of Increased Absolute Numbers of Regulatory T Cells (Treg) |
16.27; 9.87; 14.6; 9.67 | — |
| SECONDARY 2 Year Post Transplant Overall Survival (OS) Rate |
61; 69 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00803010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.