Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Diseases | Myelodysplastic/Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| methotrexate | Drug | Methotrexate | ALIAS |
| sirolimus | Drug | Sirolimus | ALIAS |
| tacrolimus | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
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