Clinical trial · Interventional
Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT
Sirolimus and Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor Hematopoietic Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
A continuation study of sirolimus and mycophenolate mofetil (MMF) for graft-vs-host disease (GvHD) prophylaxis for patients undergoing matched related allogeneic hematopoietic stem cell transplantation (HSCT) for acute and chronic leukemia, myelodysplastic syndrome (MDS), high risk non-Hodgkin lymphoma (NHL), or Hodgkin lymphoma (HL)
Conditions
Conditions (5)
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-graft-versus-host Disease | — | UNRESOLVED | — |
| Hematologic Diseases | — | UNRESOLVED | — |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Non-Hodgkin Lymphoma (NHL) | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carmustine | Drug | Carmustine | ALIAS |
| Cyclophosphamide (Cyclo, CY) | Drug | Cyclophosphamide | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| FTBI | Drug | — | UNRESOLVED |
| Mycophenolate mofetil (MMF) | Drug | — | UNRESOLVED |
| Sirolimus | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Carmustine Etoposide Cyclophosphamide
- description
- Carmustine + Etoposide + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis.
- interventionNames
- Drug: Sirolimus
- Drug: Mycophenolate mofetil (MMF)
- Drug: Carmustine
- Drug: Etoposide
- Drug: Cyclophosphamide (Cyclo, CY)
- type
- EXPERIMENTAL
- label
- FTBI + Cyclophosphamide
- description
- FTBI + Cyclophosphamide followed by Sirolimus and Mycophenolate mofetil (MMF) as prophylaxis.
- interventionNames
- Drug: Sirolimus
- Drug: Mycophenolate mofetil (MMF)
- Drug: Cyclophosphamide (Cyclo, CY)
- Drug: FTBI
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 60 Years
Show eligibility criteria text
INCLUSION CRITERIA * Acute myelogenous leukemia (AML), beyond 2nd remission or relapsed/refractory disease, age 2 to 60 years * AML, in first or subsequent remission or relapsed/refractory disease, age 51 to 60 years of age * AML with multilineage dysplasia * Acute lymphoblastic leukemia (ALL), beyond 2nd remission or relapsed/refractory disease, age 2 to 60 years * ALL, age 51 - 60 years in first or subsequent remission or relapsed/refractory disease * Chronic myeloid leukemia (CML), beyond 2nd chronic phase or in blast crisis * Myelodysplastic syndrome (MDS), including World Health Organization (WHO)classifications of refractory anemia with excess blasts-1 (RAEB-1), RAEB-2 and therapy-related MDS * MDS with poor long-term survival including myeloid metaplasia and myelofibrosis * Myeloproliferative disorders * High-risk non-Hodgkin lymphoma (NHL) in 1st emission * Relapsed or refractory NHL * Hodgkin lymphoma (HL) beyond first remission * Males and females of any ethnic background, 2 to 60 years of age * Karnofsky Performance Status (KPS) ≥ 70% or Lansky performance status \> 70% for patients \< 16 years of age. * Related, matched-donor identified \[6/6 human leukocyte antigen (HLA)-A, B and DRB1\] * Willingness to take oral medications during the transplantation period * Ability to understand and the willingness to sign a written informed consent document EXCLUSION CRITERIA * Prior myeloablative allogeneic or autologous hematopoietic stem cell transplant (HSCT) * HIV infection * Pregnant * Lactating * Evidence of uncontrolled active infection * Serum creatinine \> 1.5 mg/dL or 24-hour creatinine clearance \< 50 mL/min * Direct bilirubin, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2 x upper limit of normal (ULN) * Carbon monoxide diffusing capacity (DlCO) \< 60% predicted (adults) OR and in-room air oxygen saturation \< 92% (children) * Left ventricular ejection fraction \< 45% (adults) OR shortening fraction \< 26%(children) * Fasting cholesterol \> 300 mg/dL or Triglycerides \> 300 mg/dL while on lipid-lowering agents. * Receiving investigational drugs unless cleared by the Principal Investigator (PI). * Prior malignancies except basal cell carcinoma or treated carcinoma in-situ. * Cancer treated with curative intent ≤ 5 years (EXCEPTION BY PI DISCRETION) (Cancer treated with curative intent \> 5 years will be allowed).
References
Publications (0)
Data not yet available