Comparison Between Cyclophosphamide and Combination of Methotrexate + Calcineurin Inhibitor for GVHD Prophylaxis

• Status: Terminated
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Israelita Albert Einstein
• Treatments: Calcineurin Inhibitors; Cyclophosphamide; Methotrexate

Criteria

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.