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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00803010
First received: December 4, 2008
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

To compare the effectiveness of Tacrolimus and Rapamycin to Tacrolimus and Methotrexate in the prevention of severe graft-versus-host-disease.


Condition Intervention Phase
Acute Graft Versus Host Disease
Drug: Tacrolimus and Rapamycin (Sirolimus)
Drug: Tacrolimus and Methotrexate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase II Trial of Tacrolimus and Rapamycin vs. Tacrolimus and Methotrexate as GVHD Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • effectiveness of TAC/RAPA vs. TAC/MTX as acute GVHD prophylaxis [ Time Frame: weekly from day 0 (day of transplant) to day +100 post transplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Repopulation by regulatory T cells [ Time Frame: baseline for recipients and PBSC donors . Recipient also on days 0,on days 30, 90, 180, and 360. ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: measured post-transplant weekly for initial 12 weeks, monthly for 1 year, and thereafter every 3 months for 2nd year ] [ Designated as safety issue: No ]

Estimated Enrollment: 74
Study Start Date: September 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Tacrolimus and Rapamycin
Drug: Tacrolimus and Rapamycin (Sirolimus)

Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.

Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4mg daily.

Other Name: Sirolimus
Active Comparator: 2
Tacrolimus and Methotrexate
Drug: Tacrolimus and Methotrexate

Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuou:s IV infusion or equivalent oral dosing starting on day -3

Methotrexate: administered on day 1 at dose of 15mg/m2, and a dose of 10mg/m2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance.


  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803010

Locations
United States, Florida
H.Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Study Director: Claudio Anasetti, MD HLeeMoffittCancerCenter
  More Information

Additional Information:
No publications provided by H. Lee Moffitt Cancer Center and Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00803010     History of Changes
Other Study ID Numbers: MCC 15372, IRB 106591
Study First Received: December 4, 2008
Last Updated: June 29, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
aGVHD
GVHD
graft-versus-host disease

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Methotrexate
Sirolimus
Everolimus
Tacrolimus
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antibiotics, Antineoplastic
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 21, 2014