Acute Lymphoid Leukemia, Acute Myelogenous Leukemia, Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Myeloproliferative Disease
Conditions
Keywords
bone marrow transplantation, graft versus host disease, Acute myelogenous leukemia, Acute lymphoid leukemia, Myeloproliferative disease, Myelodysplastic syndrome, Chronic myeloid leukemia, chronic myelomonocytic leukemia
Brief 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
Detailed description
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.
Interventions
DRUGARM A Cyclophosphamide
Cyclophosphamide 50 mg/kg on day+3 and day+4 after bone marrow transplantation
DRUGARM B Calcineurin inhibitor and methotrexate
Graft versus host disease prophylaxis will be done with the combination of a calcineurin inhibitor (either tacrolimus or cyclosporine) and methotrexate
Sponsors
Hospital Israelita Albert Einstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation. | one year | The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation | one year | Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of disease relapse, one year after bone marrow transplantation | one year | Cumulative incidence of disease relapse, one year after bone marrow transplantation |
Countries
Brazil
Outcome results
None listed