Clinical trial NCT00803010: Graft-Versus-Host Disease (GVHD) Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation
Official title: Phase II Trial of Tacrolimus and Rapamycin vs. Tacrolimus and Methotrexate as GVHD Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Graft Versus Host Disease
Keywords: Acute Graft Versus Host Disease (aGVHD)
GVHD
graft-versus-host disease
tacrolimus
sirolimus
methotrexate
combination therapy
GVHD prophylaxis
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 74
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Percentage of Participants With Evidence of Acute Graft Versus Host Disease (aGVHD), Post Transplant
timeFrame: 100 Days Post Transplant
Secondary outcomes:
measure: Incidence of Increased Absolute Numbers of Regulatory T Cells (Treg)
timeFrame: 30 days and 90 days
measure: 2 Year Post Transplant Overall Survival (OS) Rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H.Lee Moffitt Cancer Center
state: Florida
Study officials:
affiliation: HLeeMoffittCancerCenter
name: Claudio Anasetti, MD
role: STUDY_DIRECTOR
References:
citation: 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.