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

Last updated: March 2, 2017
Sponsor: Hospital Israelita Albert Einstein
Overall Status: Terminated

Phase

3

Condition

Leukemia

Chronic Myeloid Leukemia

Lymphocytic Leukemia, Acute

Treatment

N/A

Clinical Study ID

NCT01749111
GEDECH-2012
  • Ages 18-60
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 (Acuteleukemia, myelodysplastic syndrome, myeloproliferative disease ormyelodysplastic/myeloproliferative disease)

  • Patients want to participate in the study, and able to give informed consent.

Exclusion

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 > threetimes the normal reference.

Study Design

Total Participants: 3
Study Start date:
December 01, 2012
Estimated Completion Date:
August 31, 2016

Study 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.

Connect with a study center

  • Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)

    São Paulo, 05652-000
    Brazil

    Site Not Available

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