Phase II Trial of Tacrolimus and Rapamycin vs. Tacrolimus and Methotrexate as GVHD Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation
Overview
- Phase
- Phase 2
- Intervention
- Tacrolimus (TAC)
- Conditions
- Acute Graft Versus Host Disease
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Evidence of Acute Graft Versus Host Disease (aGVHD), Post Transplant
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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).
Detailed Description
All drugs used in this study have been used in the prevention of graft-versus-host-disease after allogeneic hematopoietic cell transplant. Tacrolimus and Methotrexate used in combination are currently used as standard of care in the prevention of graft-versus-host-disease after allogeneic hematopoietic cell transplant. Tacrolimus and Rapamycin is a newer combination we are testing to see if it would be better than Tacrolimus and Methotrexate.
Investigators
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
Arms & Interventions
Tacrolimus / Rapamycin (TAC/RAPA)
Tacrolimus: beginning 3 days before transplant and given for at least 50 days. Rapamycin: given the day before transplant and continued daily for at least one year.
Intervention: Tacrolimus (TAC)
Tacrolimus / Rapamycin (TAC/RAPA)
Tacrolimus: beginning 3 days before transplant and given for at least 50 days. Rapamycin: given the day before transplant and continued daily for at least one year.
Intervention: Rapamycin (RAPA)
Tacrolimus / Methotrexate (TAC/MTX)
Tacrolimus: beginning 3 days before transplant and given for at least 50 days. Methotrexate: given on days 1, 3, 6 and 11, after transplant.
Intervention: Tacrolimus (TAC)
Tacrolimus / Methotrexate (TAC/MTX)
Tacrolimus: beginning 3 days before transplant and given for at least 50 days. Methotrexate: given on days 1, 3, 6 and 11, after transplant.
Intervention: Methotrexate (MTX)
Outcomes
Primary Outcomes
Percentage of Participants With Evidence of Acute Graft Versus Host Disease (aGVHD), Post Transplant
Time Frame: 100 Days Post Transplant
Incidence of acute graft versus host disease grades 2-3 according to the Common Toxicity Criteria (CTC) version 3. Graft-versus-host-disease (GVHD) is a risk associated with allogeneic hematopoietic cell transplants (HCT). Clinical evidence of acute GVHD was recorded per standard grading scheme. Acute GVHD classified as the following: 1. classic acute GVHD - onset within 100 days after transplant 2. persistent - acute GVHD with onset prior to day 100 and without resolution beyond day 100 3. recurrent - acute GVHD recurrent after prior episode of acute GVHD 4. late acute GVHD - syndrome consistent with acute GVHD, without features of chronic GVHD, with onset occurring beyond 100 days
Secondary Outcomes
- 2 Year Post Transplant Overall Survival (OS) Rate(2 years)
- Incidence of Increased Absolute Numbers of Regulatory T Cells (Treg)(30 days and 90 days)