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

Sponsor

Hospital Israelita Albert Einstein (Other)

Overall Status

Terminated

CT.gov ID

NCT01749111

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Myelogenous Leukemia Acute Lymphoid Leukemia Myeloproliferative Disease Myelodysplastic Syndrome Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia	Drug: ARM A Cyclophosphamide Drug: ARM B Calcineurin inhibitor and methotrexate	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Randomized Study to Compare Post Bone Marrow Transplant Cyclophosphamide With the Combination of Methotrexate Plus Calcineurin Inhibitor for Graft Versus Host Disease Prophylaxis

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A Graft versus host disease prophylaxis will be done with cyclophosphamide 50 mg/kg on day +3 and day +4	Drug: ARM A Cyclophosphamide Cyclophosphamide 50 mg/kg on day+3 and day+4 after bone marrow transplantation Other Names: Cyclophosphamide
Active Comparator: Arm B In this arm, patients will receive a combination of methotrexate and a calcineurin inhibitor as graft versus host disease prophylaxis	Drug: ARM 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 Other Names: Calcineurin inhibitor and methotrexate

Arm

Intervention/Treatment

Experimental: Arm A

Graft versus host disease prophylaxis will be done with cyclophosphamide 50 mg/kg on day +3 and day +4

Drug: ARM A Cyclophosphamide

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

Other Names:

Cyclophosphamide

Active Comparator: Arm B

In this arm, patients will receive a combination of methotrexate and a calcineurin inhibitor as graft versus host disease prophylaxis

Drug: ARM 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

Other Names:

Calcineurin inhibitor and methotrexate

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

Cumulative incidence of disease relapse, one year after bone marrow transplantation [one year]
Cumulative incidence of disease relapse, one year after bone marrow transplantation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.