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

March 2, 2017 updated by: Paulo Vidal Campregher, Hospital Israelita Albert Einstein

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05652-000
        • Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Graft versus host disease prophylaxis will be done with cyclophosphamide 50 mg/kg on day +3 and day +4
Drug: ARM A Cyclophosphamide
Cyclophosphamide 50 mg/kg on day+3 and day+4 after bone marrow transplantation
Other Names:
  • Cyclophosphamide
Active Comparator: Arm B
In this arm, patients will receive a combination of methotrexate and a calcineurin inhibitor as graft versus host disease prophylaxis
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
Other Names:
  • Calcineurin inhibitor and methotrexate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
Time Frame: one year
The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation
Time Frame: one year
Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation
one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of disease relapse, one year after bone marrow transplantation
Time Frame: one year
Cumulative incidence of disease relapse, one year after bone marrow transplantation
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Investigators

  • Principal Investigator: Paulo V Campregher, MD, Hospital Israelita Albert Einstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

December 12, 2012

First Posted (Estimate)

December 13, 2012

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEDECH-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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