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

NCT01749111 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-03-03

No results posted yet for this 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

Conditions

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

Interventions

DRUG

ARM A Cyclophosphamide

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

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

Sponsors & Collaborators

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Paulo V Campregher, MD · Hospital Israelita Albert Einstein

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01749111 on ClinicalTrials.gov