Clinical trial · Interventional
Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Related Stem Cell Transplantation
Open Label Phase II Trial of Sirolimus in Combination With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Matched, Related Allogeneic Hematopoietic Stem Cell Transplantation
NCT00144703CI-TRIAL-00006140completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 a related donor.
Conditions
Conditions (6)
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 |
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Myelogenous Leukemia | Myeloid Leukemia | 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 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 controls
- measure
- to determine the incidence of 100 day mortality after stem cell transplant using this regimen
- measure
- to determine the overall survival at 1 year after transplantation in this patient population.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with hematologic malignancies who will undergo allogeneic HSCT from matched family-members. * Age greater than 18 * ECOG performance status 0-2 * Total bilirubin \< 2.0 mg/dl * AST \< 90 IU * Serum creatinine \< 2.0 mg/dl Exclusion Criteria: * Active, uncontrolled infection * Ejection fraction \< 45% by echocardiogram or MUGA scan * Forced vital capacity \< 60% * Uncontrolled hypertension * Second transplantation * Evidence of HIV infection * Cholesterol \> 300 mg/dl * Relapsed aggressive Burkitt's or Burkitt's-like lymphoma
References
Publications (0)
Data not yet available
No reference posted for this study.