Phase 2 Completed N=74 Randomized Prevention

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

Source: ClinicalTrials.gov NCT00803010 ↗

Enrolled (actual)

Serious AEs

6.8%

Results posted

May 2014

Primary outcomePrimary: Percentage of Participants With Evidence of Acute Graft Versus Host Disease (aGVHD), Post Transplant — 43; 89 percentage of participants

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).

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.