Graft-Versus-Host Disease (GVHD) Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation
Phase II Trial of Tacrolimus and Rapamycin vs. Tacrolimus and Methotrexate as GVHD Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation
2 other identifiers
interventional
74
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 4, 2008
CompletedFirst Posted
Study publicly available on registry
December 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
May 5, 2014
CompletedJuly 31, 2015
December 1, 2013
4.3 years
December 4, 2008
December 10, 2013
July 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Evidence of Acute Graft Versus Host Disease (aGVHD), 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
100 Days Post Transplant
Secondary Outcomes (2)
Incidence of Increased Absolute Numbers of Regulatory T Cells (Treg)
30 days and 90 days
2 Year Post Transplant Overall Survival (OS) Rate
2 years
Study Arms (2)
Tacrolimus / Rapamycin (TAC/RAPA)
ACTIVE COMPARATORTacrolimus: 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.
Tacrolimus / Methotrexate (TAC/MTX)
ACTIVE COMPARATORTacrolimus: beginning 3 days before transplant and given for at least 50 days. Methotrexate: given on days 1, 3, 6 and 11, after transplant.
Interventions
Tacrolimus: administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.
Methotrexate: administered on day 1 at dose of 15 mg/m\^2, and a dose of 10 mg/m\^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance.
Rapamycin: initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily.
Eligibility Criteria
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
- or more Sorror's factors with composite score of ≥ 3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
H.Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Related Publications (1)
Pidala J, Kim J, Jim H, Kharfan-Dabaja MA, Nishihori T, Fernandez HF, Tomblyn M, Perez L, Perkins J, Xu M, Janssen WE, Veerapathran A, Betts BC, Locke FL, Ayala E, Field T, Ochoa L, Alsina M, Anasetti C. A randomized phase II study to evaluate tacrolimus in combination with sirolimus or methotrexate after allogeneic hematopoietic cell transplantation. Haematologica. 2012 Dec;97(12):1882-9. doi: 10.3324/haematol.2012.067140. Epub 2012 Jun 11.
PMID: 22689677DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Joseph Pidala
- Organization
- H. Lee Moffitt Cancer Center
Study Officials
- STUDY DIRECTOR
Claudio Anasetti, MD
HLeeMoffittCancerCenter
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2008
First Posted
December 5, 2008
Study Start
September 1, 2008
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 31, 2015
Results First Posted
May 5, 2014
Record last verified: 2013-12