NCT00089037

Sirolimus, Tacrolimus, and Methotrexate in Preventing Acute Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplantation

A Phase I/II Study of Sirolimus in Addition to Tacrolimus and Methotrexate for the Prevention of Acute-Graft-Versus-Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplantation From Unrelated Donors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Sirolimus, tacrolimus, and methotrexate may be effective in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation. 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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Chronic Myeloproliferative Disorders
• Graft Versus Host Disease
• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Diseases

Interventions

Type	Name	Description
DRUG	methotrexate
DRUG	sirolimus
DRUG	tacrolimus

Timeline

• Start date: 2003-06-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2004-08-05
• Last updated: 2011-07-15

Locations

1 site across 1 country: United States