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

Hospital Israelita Albert Einstein

Status and phase: Terminated; Phase 3

Conditions: Acute Myelogenous Leukemia; Myeloproliferative Disease; Acute Lymphoid Leukemia; Chronic Myeloid Leukemia; Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia

Treatments: Drug: ARM A Cyclophosphamide; Drug: ARM B Calcineurin inhibitor and methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT01749111

GEDECH-2012

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Arm A

Experimental group

Description:

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

Treatment:

Drug: ARM A Cyclophosphamide

Arm B

Active Comparator group

Description:

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

Treatment:

Drug: ARM B Calcineurin inhibitor and methotrexate