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PURPOSE: This phase I/II trial is studying the side effects of sirolimus when given together with tacrolimus and methotrexate and to see how well they work in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation for hematologic cancer.
- Determine the safety and efficacy of sirolimus when administered with tacrolimus and methotrexate for the prevention of acute graft-versus-host disease (GVHD) in patients with hematological malignancies undergoing hematopoietic stem cell transplantation from unrelated donors.
- Determine the absorption and pharmacokinetics of sirolimus in patients treated with this regimen.
- Correlate sirolimus blood concentration with prevention of GVHD or toxicity in patients treated with this regimen.
- Determine the severity of post-transplantation mucositis in patients treated with this regimen.
OUTLINE: This is a nonrandomized, open-label, pilot study.
Patients receive oral sirolimus once daily on days -3 to 175 and tacrolimus IV continuously beginning on day -3 and continuing until the patient is able to tolerate food and then orally twice daily until day 175. Patients also receive methotrexate IV on days 1, 3, 6, and 11. Treatment continues in the absence of acute graft-vs-host disease or unacceptable toxicity.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 3 years.
Masking: Open Label, Primary Purpose: Supportive Care
Chronic Myeloproliferative Disorders
methotrexate, sirolimus, tacrolimus
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:54:10-0400
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A family of immunophilin proteins that bind to the immunosuppressive drugs TACROLIMUS (also known as FK506) and SIROLIMUS. EC 5.2.1.-
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...