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

Phase 3TerminatedNCT01749111

Hospital Israelita Albert Einstein3 enrolled

Overview

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

We propose a study in which 150 patients will receive graft versus host disease prophylaxis with cyclophosphamide 50 mg/kg on day +3 and day +4 after bone marrow transplantation, and 150 patients will receive the usual combination of methotrexate and calcineurin inhibitor. The study was designed to last for 4 years. The primary endpoint is the rate of patients alive, in remission and without immunosuppression, one year after transplant. The assignment for each arm of the study will be done through simple randomization.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Acute Myelogenous Leukemia Acute Lymphoid Leukemia Myeloproliferative Disease

Interventions

ARM A CyclophosphamideDRUG

Cyclophosphamide 50 mg/kg on day+3 and day+4 after bone marrow transplantation

ARM B Calcineurin inhibitor and methotrexateDRUG

Graft versus host disease prophylaxis will be done with the combination of a calcineurin inhibitor (either tacrolimus or cyclosporine) and methotrexate

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.

Time frame: one year

Secondary Outcomes

Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation