Clinical Trials Directory

Trials / Terminated

TerminatedNCT01749111

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

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

Status
Terminated
Phase
Phase 3
Study type
Interventional
Enrollment
3 (actual)
Sponsor
Hospital Israelita Albert Einstein · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGARM A CyclophosphamideCyclophosphamide 50 mg/kg on day+3 and day+4 after bone marrow transplantation
DRUGARM B Calcineurin inhibitor and methotrexateGraft versus host disease prophylaxis will be done with the combination of a calcineurin inhibitor (either tacrolimus or cyclosporine) and methotrexate

Timeline

Start date
2012-12-01
Primary completion
2016-08-01
Completion
2016-08-01
First posted
2012-12-13
Last updated
2017-03-03

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01749111. Inclusion in this directory is not an endorsement.