Completed

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

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What is being tested

Data Collection

Who is being recruted

Blood Protein Disorders+25

+ Bone Marrow Diseases

+ Cardiovascular Diseases

See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 1 & 2
Interventional
Study Start: June 2003
See protocol details

Summary

Principal SponsorFred Hutchinson Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleA 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 
NCT00089037
Principal SponsorFred Hutchinson Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersBone Marrow DiseasesCardiovascular DiseasesDiseaseGraft vs Host DiseaseHematologic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLeukemiaLymphatic DiseasesLymphomaLymphoproliferative DisordersMultiple MyelomaMyelodysplastic SyndromesMyeloproliferative DisordersNeoplasmsNeoplasms by Histologic TypeParaproteinemiasPathologic ProcessesPlasmacytomaPrecancerous ConditionsPreleukemiaSyndromeVascular DiseasesHemostatic DisordersNeoplasms, Plasma CellMyelodysplastic-Myeloproliferative Diseases

Criteria

DISEASE CHARACTERISTICS: * Diagnosis of hematological malignancy * No chronic phase chronic myelogenous leukemia, de novo acute leukemia in first remission, or myelodysplastic syndromes with refractory anemia * Scheduled for hematopoietic stem cell transplantation from unrelated donors * Currently receiving conditioning regimen comprising cyclosporine and total body radiotherapy (1,200 to 1,350 cGy) or busulfan and cyclosporine * Donor must be typed to the highest level of resolution * One single non-serologic disparity for A, B, or C alleles allowed provided the disparity is within the third or fourth digit of the allele * No mismatch at DRB1 or DQB1 PATIENT CHARACTERISTICS: Age * Per primary treatment protocol Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * SGOT and SGPT ≤ 2.0 times upper limit of normal * Bilirubin normal * Hepatitis B and C virus negative Renal * Creatinine clearance ≥ 70 mL/min Cardiovascular * No cardiac insufficiency requiring treatment * No coronary artery disease Pulmonary * No acute pulmonary infection by chest x-ray * No severe hypoxemia with pO_2 \< 70 mm Hg AND DLCO \< 70% of predicted * No mild hypoxemia with pO_2 \< 80 mm Hg AND DLCO \< 60% of predicted Other * Not pregnant or nursing * Negative pregnancy test * HIV negative * No active systemic infection * No known hypersensitivity to macrolide antibiotics (e.g., erythromycin, azithromycin, or clarithromycin) * No prior intolerance or unresponsiveness to sirolimus PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No concurrent T-cell depleted transplantations Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * Not specified Other * No concurrent grapefruit juice * No concurrent voriconazole

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Fred Hutchinson Cancer Research Center

Seattle, United StatesSee the location
CompletedOne Study Center