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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-08-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Acute Myelogenous Leukemia Acute Lymphoid Leukemia Myeloproliferative Disease Myelodysplastic Syndrome Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm A

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

Group Type EXPERIMENTAL

ARM A Cyclophosphamide

Intervention Type DRUG

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

Arm B

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

Group Type ACTIVE_COMPARATOR

ARM B Calcineurin inhibitor and methotrexate

Intervention Type DRUG

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

Interventions

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ARM A Cyclophosphamide

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Cyclophosphamide Calcineurin inhibitor and methotrexate

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No