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
NCT00350181CI-TRIAL-00054043completedPhase 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)
GVHD prophylaxis of sirolimus and mycophenolate mofetil for patients undergoing matched related allogeneic transplant for acute and chronic leukemia, MDS, high risk NHL and HL
Conditions
Conditions (4)
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 GVHD | — | UNRESOLVED | — |
| Hematologic Diseases | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCNU | Drug | Carmustine | ALIAS |
| BU | Drug | — | UNRESOLVED |
| CY | Drug | — | UNRESOLVED |
| FTBI | Drug | — | UNRESOLVED |
| MMF | Drug | — | UNRESOLVED |
| Sirolimus | Drug | Sirolimus | ALIAS |
| VP-16 | Drug | Etoposide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Regimen Treatment 1
- description
- For subjects 18-60 years old with lymphoma: (BCNU+ VP-16 +CY) BCNU 15 mg / kg (maximum dose 550 mg/m² actual body weight) on day -6. VP 60 mg / kg on day 4 and CY 100 mg / kg on day -2. Followed by Sirolimus and MMF as prophylaxis
- interventionNames
- Drug: Sirolimus
- Drug: MMF
- Drug: BCNU
- Drug: VP-16
- Drug: CY
- type
- EXPERIMENTAL
- label
- Regimen Treatment 2
- description
- For subjects 18-50 years old with AML, ALL or CML: (VP-16 +CY+ FBI) Patients aged 18-50 years with AML, ALL or CML: FTBI 1320 cGy delivered in 11 120 cGy fractions over 4 days on days -8 through -5. VP 60 mg / kg on day -4 and CY 60 mg / kg on day -2. Followed by Sirolimus and MMF as prophylaxis
- interventionNames
- Drug: Sirolimus
- Drug: MMF
- Drug: VP-16
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Disease Categories: (one of the following) * AML, age 2 - 60 years beyond 2nd remission or relapsed/refractory disease * AML, age 51-60 years of age, in first or subsequent remission or relapsed/refractory disease * AML with multilineage dysplasia * ALL, age 2 - 60 years beyond 2nd remission or relapsed/refractory disease * ALL, age 51 - 60 years in first or subsequent remission or relapsed/refractory disease * CML Beyond 2nd chronic phase or in blast crisis * MDS; Includes World Health Organization classifications of refractory anemia with excess blasts-1 (RAEB-1), RAEB-2 and therapy-related MDS * Myeloproliferative disorders; MDS with poor long-term survival including myeloid metaplasia and myelofibrosis * High risk NHL in first remission * Relapsed or refractory NHL * HL beyond first remission * Males and females of any ethnic background 2 - 60 years of age * Karnofsky Performance Status ≥ 70% or Lansky performance status \> 70% for patients \< 16 years of age. * Matched related donor identified: 6/6 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 HCT * HIV infection * Pregnant * Lactating females * Evidence of uncontrolled active infection * Organ Dysfunction: * Serum creatinine \> 1.5 mg/dL or 24 hour creatinine clearance \< 50 ml/min * Direct bilirubin, ALT or AST \> 2 x ULN * In adults DLCO \< 60% predicted and in children room air oxygen saturation \< 92% * In adults, left ventricular ejection fraction \< 45% and in children, shortening fraction \< 26% * Fasting Cholesterol \> 300 mg/dL or Triglycerides \> 300 mg/dL while on lipid-lowering agents. * Patients receiving investigational drugs unless cleared by the PI. * Patients with prior malignancies except basal cell carcinoma or treated carcinoma in-situ. * Cancer treated with curative intent \> 5 years will be allowed. * Cancer treated with curative intent ≤ 5 years will not be allowed with PI approval.
References
Publications (1)
- RESULTJohnston L, Florek M, Armstrong R, McCune JS, Arai S, Brown J, Laport G, Lowsky R, Miklos D, Shizuru J, Sheehan K, Lavori P, Negrin R. Sirolimus and mycophenolate mofetil as GVHD prophylaxis in myeloablative, matched-related donor hematopoietic cell transplantation. Bone Marrow Transplant. 2012 Apr;47(4):581-8. doi: 10.1038/bmt.2011.104. Epub 2011 May 9. PMID 21552302