Clinical trial · Interventional
Tacrolimus and Mycophenolate Mofetil in Preventing Acute Graft-Versus-Host Disease in Patients With Advanced Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplantation
A Phase II Study of the Combination of Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-Versus-Host Disease
- 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: Tacrolimus and mycophenolate mofetil may be an effective treatment for graft-versus-host disease caused by donor stem cell transplantation. PURPOSE: This phase II trial is studying how well giving tacrolimus together with mycophenolate mofetil works in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation for advanced 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mycophenolate mofetil | Drug | — | UNRESOLVED |
| tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Efficacy
Secondary outcomes (2)
- measure
- Safety
- measure
- Area under the curve of plasma mycophenolic acid
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following hematologic malignancies: * Acute myeloid leukemia beyond first complete remission (CR1) * Acute lymphoblastic leukemia beyond CR1 * Chronic myelogenous leukemia in second chronic phase, accelerated phase, or blastic phase * Non-Hodgkin's lymphoma beyond CR2 * Hodgkin's lymphoma beyond CR2 * Multiple myeloma (any stage) * Myelodysplastic syndromes beyond refractory anemia (including chronic myelomonocytic leukemia) * Any refractory hematologic malignancy * Advanced disease * Scheduled for transplantation of mobilized allogeneic peripheral blood stem cells * Genotypically HLA-identical stem cell donor available PATIENT CHARACTERISTICS: Age * 65 and under Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * SGOT and SGPT ≤ 2.0 times ULN Renal * Creatinine clearance ≥ 60 mL/min Pulmonary * No acute pulmonary infection by chest x-ray * No severe hypoxemia (partial O\_2 \< 70% of predicted) AND DLCO \< 70% of predicted * No mild hypoxemia (partial O\_2 \< 80% of predicted) AND DLCO \< 60% of predicted Other * Not pregnant or nursing * Negative pregnancy test * No active systemic infection not controlled with antimicrobial therapy * HIV negative (HIV-1 or other virus) PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent T-cell depleted hematopoietic stem cell graft Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
References
Publications (0)
Data not yet available