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Sponsored by: |
H. Lee Moffitt Cancer Center and Research Institute |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00360685 |
A comparative trial where all patients will receive daily doses of tacrolimus (TAC) until day +60 when tapering will begin, in the absence of graft-versus-host disease (GVHD), and discontinued by day +180. In addition patients will be randomized to methotrexate (MTX) or mycophenolate mofetil (MMF) and again, in the absence of GVHD, a tapering schedule will begin on day +240 and be completed on day +360. Doses will be adjusted to maintain blood levels.
Condition | Intervention |
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Mucositis Graft-Versus-Host Disease |
Drug: tacrolimus (TAC) Drug: mycophenolate mofetil (MMF) Drug: methotrexate (MTX) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety of Tacrolimus And Methotrexate (MTX) Versus Tacrolimus And Mycophenolate Mofetil (MMF) As Graft Versus Host Disease Prophylaxis In Allogeneic Hematopoietic Cell Transplants (HCT) |
Estimated Enrollment: | 95 |
Study Start Date: | October 2005 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
The randomization for this comparative trial will be stratified by conditioning regimen and, for those patients enrolled on MCC-14178, by busulfan AUC level.
All patients will receive daily doses of TAC beginning day -3 (day 0 being the day of hematopoietic stem cell transplant (HCT)) and will be given until day +60 when tapering will begin in the absence of GVHD. Provided no GVHD develops, TAC should be discontinued by day +180. Doses will be adjusted to maintain blood levels.
In addition to TAC, patients will be randomized to one of the following additional anti-GVHD medications: MTX or MMF beginning day 0 at least 2 hours after the end of the HCT. In the absence of GVHD a tapering schedule will begin on day +240 and be completed on day +360.
Study participants will be extensively monitored as inpatients and then weekly as outpatients. Some tests will be conducted at least twice weekly (blood tests, toxicity data, GVHD and physical exams) one-month post-transplant and during the tapering off periods for up to 2 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient must be going through a T cell-replete allogeneic transplant
Exclusion Criteria:
- A contraindication to the use of tacrolimus, mycophenolate, or methotrexate
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | |
Tampa, Florida, United States, 33612 |
Principal Investigator: | Janelle Perkins, PharmD | H. Lee Moffitt Cancer Center and Research Institute |
Principal Investigator: | Teresa Field, PhD, MD | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center & Research Institute ( Jeffrey Lancet, MD ) |
Study ID Numbers: | MCC-14418 |
Study First Received: | August 3, 2006 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00360685 |
Health Authority: | United States: Food and Drug Administration |
Tacrolimus Methotrexate Mycophenolate mofetil Mucositis |
Acute graft-versus-host disease (aGVHD) Engraftment hemolytic/uremic syndrome (HUS) Thrombotic thrombocytopenic purpura (TTP) |
Purpura Mouth Diseases Mucositis Gastrointestinal Diseases Graft versus host disease Mycophenolic Acid Tacrolimus Purpura, Thrombotic Thrombocytopenic Purpura, Thrombocytopenic |
Homologous wasting disease Folic Acid Digestive System Diseases Mycophenolate mofetil Graft vs Host Disease Methotrexate Stomatognathic Diseases Gastroenteritis |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents Antibiotics, Antineoplastic |
Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |