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

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ClinicalTrials.gov Identifier: NCT01749111
Recruitment Status : Terminated (Lack of accrual)
First Posted : December 13, 2012
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Paulo Vidal Campregher, Hospital Israelita Albert Einstein

Tracking Information
First Submitted Date  ICMJE December 11, 2012
First Posted Date  ICMJE December 13, 2012
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE December 2012
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2012)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 12, 2012)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Comparison Between Cyclophosphamide and Combination of Methotrexate + Calcineurin Inhibitor for GVHD Prophylaxis
Official Title  ICMJE Randomized Study to Compare Post Bone Marrow Transplant Cyclophosphamide With the Combination of Methotrexate Plus Calcineurin Inhibitor for Graft Versus Host Disease Prophylaxis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Acute Myelogenous Leukemia
  • Acute Lymphoid Leukemia
  • Myeloproliferative Disease
  • Myelodysplastic Syndrome
  • Chronic Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
Intervention  ICMJE
  • Drug: ARM A Cyclophosphamide
    Cyclophosphamide 50 mg/kg on day+3 and day+4 after bone marrow transplantation
    Other Name: Cyclophosphamide
  • 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 Name: Calcineurin inhibitor and methotrexate
Study Arms  ICMJE
  • Experimental: Arm A
    Graft versus host disease prophylaxis will be done with cyclophosphamide 50 mg/kg on day +3 and day +4
    Intervention: Drug: ARM A 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
    Intervention: Drug: ARM B Calcineurin inhibitor and methotrexate
Publications * Luznik L, Bolaños-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 2, 2017)
3
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2012)
300
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01749111
Other Study ID Numbers  ICMJE GEDECH-2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paulo Vidal Campregher, Hospital Israelita Albert Einstein
Study Sponsor  ICMJE Hospital Israelita Albert Einstein
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paulo V Campregher, MD Hospital Israelita Albert Einstein
PRS Account Hospital Israelita Albert Einstein
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP