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

Primary Purpose

Acute Myelogenous Leukemia, Acute Lymphoid Leukemia, Myeloproliferative Disease

Status
Terminated
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
ARM A Cyclophosphamide
ARM B Calcineurin inhibitor and methotrexate
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Myelogenous Leukemia focused on measuring bone marrow transplantation, graft versus host disease, Acute myelogenous leukemia, Acute lymphoid leukemia, Myeloproliferative disease, Myelodysplastic syndrome, Chronic myeloid leukemia, chronic myelomonocytic leukemia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

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

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

Outcomes

Primary Outcome Measures

The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.

Secondary Outcome Measures

Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation
Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation

Full Information

First Posted
December 11, 2012
Last Updated
March 2, 2017
Sponsor
Hospital Israelita Albert Einstein
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1. Study Identification

Unique Protocol Identification Number
NCT01749111
Brief Title
Comparison Between Cyclophosphamide and Combination of Methotrexate + Calcineurin Inhibitor for GVHD Prophylaxis
Acronym
CICLODECH
Official Title
Randomized Study to Compare Post Bone Marrow Transplant Cyclophosphamide With the Combination of Methotrexate Plus Calcineurin Inhibitor for Graft Versus Host Disease Prophylaxis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of accrual
Study Start Date
December 2012 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Israelita Albert Einstein

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia, Acute Lymphoid Leukemia, Myeloproliferative Disease, Myelodysplastic Syndrome, Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
Keywords
bone marrow transplantation, graft versus host disease, Acute myelogenous leukemia, Acute lymphoid leukemia, Myeloproliferative disease, Myelodysplastic syndrome, Chronic myeloid leukemia, chronic myelomonocytic leukemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Graft versus host disease prophylaxis will be done with cyclophosphamide 50 mg/kg on day +3 and day +4
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
In this arm, patients will receive a combination of methotrexate and a calcineurin inhibitor as graft versus host disease prophylaxis
Intervention Type
Drug
Intervention Name(s)
ARM A Cyclophosphamide
Other Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide 50 mg/kg on day+3 and day+4 after bone marrow transplantation
Intervention Type
Drug
Intervention Name(s)
ARM B Calcineurin inhibitor and methotrexate
Other Intervention Name(s)
Calcineurin inhibitor and methotrexate
Intervention Description
Graft versus host disease prophylaxis will be done with the combination of a calcineurin inhibitor (either tacrolimus or cyclosporine) and methotrexate
Primary Outcome Measure Information:
Title
The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
Description
The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation
Description
Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
Cumulative incidence of disease relapse, one year after bone marrow transplantation
Description
Cumulative incidence of disease relapse, one year after bone marrow transplantation
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo V Campregher, MD
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)
City
São Paulo
ZIP/Postal Code
05652-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
20124511
Citation
Luznik L, Bolanos-Meade J, Zahurak M, Chen AR, Smith BD, Brodsky R, Huff CA, Borrello I, Matsui W, Powell JD, Kasamon Y, Goodman SN, Hess A, Levitsky HI, Ambinder RF, Jones RJ, Fuchs EJ. High-dose cyclophosphamide as single-agent, short-course prophylaxis of graft-versus-host disease. Blood. 2010 Apr 22;115(16):3224-30. doi: 10.1182/blood-2009-11-251595. Epub 2010 Feb 2.
Results Reference
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Comparison Between Cyclophosphamide and Combination of Methotrexate + Calcineurin Inhibitor for GVHD Prophylaxis

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