Clinical trial · Interventional
Sirolimus and Mycophenolate Mofetil in Preventing GVHD in Patients With Hematologic Malignancies Undergoing HSCT
Pilot Safety and Feasibility Trial of Mycophenolate and Sirolimus for Prevention of GVHD in Mismatched Unrelated and Related Donor Hematopoietic Stem Cell Transplantation for Hematologic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Accrual factor
Summary
Brief summary (as posted)
This pilot phase I/II trial studies the side effects and how well sirolimus and mycophenolate mofetil work in preventing graft versus host disease (GvHD) in patients with hematologic malignancies undergoing hematopoietic stem cell transplant (HSCT). Biological therapies, such as sirolimus and mycophenolate mofetil, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Giving sirolimus and mycophenolate mofetil after hematopoietic stem cell transplant may be better in preventing graft-versus-host disease.
Conditions
Conditions (18)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Hodgkin Lymphoma | Adult Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Adult Myelodysplastic Syndrome | Adult Myelodysplastic Syndrome | ONTOLOGY_EXACT | 0.98 |
| Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Childhood Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Childhood Hodgkin Lymphoma | Childhood Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Childhood Myelodysplastic Syndrome | Childhood Myelodysplastic Syndrome | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Mycophenolate Mofetil | Drug | — | UNRESOLVED |
| Sirolimus | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (sirolimus, HSCT, MMF)
- description
- Patients receive sirolimus PO starting on day -3, 3 times a week during hospitalization and then once a week for up to 6 months. Patients undergo HSCT on day 0. Patients also receive mycophenolate mofetil IV or PO TID on days 1-180. Treatment continues in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- Other: Laboratory Biomarker Analysis
- Drug: Mycophenolate Mofetil
- Drug: Sirolimus
Primary outcomes (2)
- measure
- Incidence of acute GvHD grade 3 & 4, according to the Glucksberg staging criteria
- timeFrame
- Up to 60 days post-transplant
- description
- Statistical analysis results will be reported using summary tables, figures, and data listings. Continuous variables will be summarized using the mean, standard deviation, median, minimum, and maximum.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must have one of the following disease categories: * Acute myeloid leukemia (AML) beyond 2nd remission or relapsed/refractory disease * Acute lymphoblastic leukemia (ALL) beyond 2nd remission or relapsed/refractory disease * Chronic myeloid leukemia (CML) beyond 2nd chronic phase or in blast crises * Myelodysplastic syndrome (MDS) * Myeloproliferative disorders including myeloid metaplasia and myelofibrosis * High risk non-Hodgkin's lymphoma (NHL) in first remission * Relapsed or refractory NHL * Hodgkin's lymphoma (HL) beyond first remission * Performance status by Karnofsky of \>= 70% or Lansky \> 70% for patients \< 16 years of age * Human leukocyte antigen (HLA) mismatched related or unrelated donor identified 8/10 or 9/10 * Willingness to take oral medications during the transplantation period * Willingness and ability to sign a written informed consent (assent if applicable) Exclusion Criteria: * Prior myeloablative allogeneic or autologous HSCT * Human immunodeficiency virus (HIV) infection * Pregnant or lactating females * Evidence of uncontrolled active infection * Down syndrome * Serum creatinine (CR) \< 1.5mg/dl or 24 hour CR clearance \< 50 ml/min * Direct bilirubin \> 2 x upper limit of normal (ULN) * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 x ULN * Carbon monoxide diffusing capability test (DLCO) \> 60% predicted and in children- room air oxygen saturation \> 92% * Left ventricular ejection fraction \< 45% and in children-shortening fraction \< 26% * Fasting cholesterol \> 300 mg/dl or triglycerides \> 300 while on lipid lowering agents * Patients who have received an investigational drug within 30 days of enrollment in study * Patients with prior malignancies except basal cell carcinoma or treated carcinoma in-situ; cancer treated with curative intent \> 5 years will be allowed; cancer treatment with curative intent =\< 5 years will not be allowed
References
Publications (0)
Data not yet available