Clinical trial · Interventional
Comparison Between Cyclophosphamide and Combination of Methotrexate + Calcineurin Inhibitor for GVHD Prophylaxis
Randomized Study to Compare Post Bone Marrow Transplant Cyclophosphamide With the Combination of Methotrexate Plus Calcineurin Inhibitor for Graft Versus Host Disease Prophylaxis
NCT01749111CI-TRIAL-00026223CICLODECHterminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of accrual
Summary
Brief summary (as posted)
The purpose of this study is to determine whether cyclophosphamide post bone marrow transplant increases the rate of patients alive, in remission and without immunosuppression, one year after transplant, when compared with the combination of methotrexate and calcineurin inhibitor
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 Lymphoid Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Chronic Myelomonocytic Leukemia | Chronic Myelomonocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Myeloproliferative Disease | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARM A Cyclophosphamide | Drug | — | UNRESOLVED |
| ARM B Calcineurin inhibitor and methotrexate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Graft versus host disease prophylaxis will be done with cyclophosphamide 50 mg/kg on day +3 and day +4
- interventionNames
- Drug: ARM A Cyclophosphamide
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- In this arm, patients will receive a combination of methotrexate and a calcineurin inhibitor as graft versus host disease prophylaxis
- interventionNames
- Drug: ARM B Calcineurin inhibitor and methotrexate
Primary outcomes (1)
- measure
- The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Man or woman 18 to 60 years of age. * The patient should have a HLA matched donor * The patient must need a bone marrow transplant for a malignant disease (Acute leukemia, myelodysplastic syndrome, myeloproliferative disease or myelodysplastic/myeloproliferative disease) * Patients want to participate in the study, and able to give informed consent. Exclusion Criteria: * Previous auto o allogeneic hematopoietic stem cell transplant * Performance Status \>2 (ECOG). * Pregnancy * HIV positive * Active Infection * Cardiac disease with ejection fraction \< 45% * Lung disease with FEV1, FVC ou DLCO \<50% of predicted values. * Renal Insufficiency with creatinine clearance \< 60 ml/minute. * Liver disease with bilirubin levels \> twice the reference value or ALT or AST \> three times the normal reference.
References
Publications (1)
- BACKGROUNDLuznik L, Bolanos-Meade J, Zahurak M, Chen AR, Smith BD, Brodsky R, Huff CA, Borrello I, Matsui W, Powell JD, Kasamon Y, Goodman SN, Hess A, Levitsky HI, Ambinder RF, Jones RJ, Fuchs EJ. High-dose cyclophosphamide as single-agent, short-course prophylaxis of graft-versus-host disease. Blood. 2010 Apr 22;115(16):3224-30. doi: 10.1182/blood-2009-11-251595. Epub 2010 Feb 2. PMID 20124511