Clinical trial · Interventional
Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation
Open Label Phase II Trial of Sirolimus in Combination With Tacrolimus for Graft-vs-Host Disease Prophylaxis After HLA-Matched, Unrelated, Allogeneic Hematopoietic Stem Cell Transplantation
- 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)
The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus host disease (GVHD) in patients following stem cell transplant from an unrelated donor. This trial is designed to test the hypothesis that elimination of methotrexate in the unrelated donor group would lead to less transplant-related toxicity while still preserving the effective control of GVHD.
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 |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sirolimus | Drug | Sirolimus | ALIAS |
| tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the feasibility of using a combination of sirolimus and tacrolimus without methotrexate for GVHD prophylaxis after stem cell transplantation.
Secondary outcomes (3)
- measure
- To compare the rates of grade II-IV and III-IV acute GVHD with historical control
- measure
- to determine the incidence of 100 day mortality using this GVHD prophylaxis regimen
- measure
- to determine the overall survival after one year of this patient population.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Acute myelogenous leukemia(AML) in first or subsequent remission, in untreated first relapse or any treated relapse. * Acute lymphoblastic leukemia(ALL) in first or subsequent remission, in untreated first relapse or any treated relapse. * Chronic myelogenous leukemia in first or second chronic stable phase or in accelerated phase. * Myelodysplastic syndromes or myeloproliferative diseases * Non-Hodgkin's lymphoma or Hodgkin's disease in second or greater complete remission, in partial remission, or induction failure. * Chronic lymphocytic leukemia, Rai stage 2-4, which has progressed after initial therapy. * Matched unrelated donor. * Age 18-55 years at the time of stem cell transplantation * ECOG performance status 0-2 * Life expectancy of 100 days without stem cell transplantation * Total bilirubin \< 2.0 mg/dl * AST \< 90 IU * Serum creatinine \< 2.0 mg/dl * Ejection fraction \> 40% by echocardiogram or gated nuclear medicine study. Exclusion Criteria: * Uncontrolled infection * Forced vital capacity or DLCO \< 50% predicted for age * Uncontrolled hypertension * Prior hematopoietic stem cell transplant * Evidence of HIV infection or active Hepatitis B or C infection * Cholesterol \> 300 mg/dl * Relapsed aggressive Burkitt's or Burkitt's-like lymphoma
References
Publications (0)
Data not yet available