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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Hospital Israelita Albert Einstein
Sponsor:
Information provided by (Responsible Party):
Paulo Vidal Campregher, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier:
NCT01749111
First received: December 11, 2012
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Acute Myelogenous Leukemia
Acute Lymphoid Leukemia
Myeloproliferative Disease
Myelodysplastic Syndrome
Chronic Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Drug: ARM A Cyclophosphamide
Drug: ARM B Calcineurin inhibitor and methotrexate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Hospital Israelita Albert Einstein:

Primary Outcome Measures:
  • The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation. [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year ] [ Designated as safety issue: No ]
    Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation


Other Outcome Measures:
  • Cumulative incidence of disease relapse, one year after bone marrow transplantation [ Time Frame: one year ] [ Designated as safety issue: No ]
    Cumulative incidence of disease relapse, one year after bone marrow transplantation


Estimated Enrollment: 300
Study Start Date: December 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Calcineurin inhibitor and methotrexate

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749111

Contacts
Contact: Sandra S Nakashima, Nurse 0055 11 2151 1128 sandra.nakashima@einstein.br
Contact: Isabel C Bello, Nurse 0055 11 2151 1128 isabel.bello@einstein.br

Locations
Brazil
Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP) Recruiting
São Paulo, Brazil, 05652-000
Contact: Sandra S Nakashima, Nurse    0055 11 2151 1128    sandra.nakashima@einstein.br   
Contact: Isabel C Bello, Nurse    0055 11 2151 1128    isabel.bello@einstein.br   
Principal Investigator: Paulo V Campregher, MD         
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Investigators
Principal Investigator: Paulo V Campregher, MD Hospital Israelita Albert Einstein
  More Information

Publications:
Responsible Party: Paulo Vidal Campregher, MD, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT01749111     History of Changes
Other Study ID Numbers: GEDECH-2012
Study First Received: December 11, 2012
Last Updated: December 12, 2012
Health Authority: Brazil: Agência Nacional de Vigilância Sanitária

Keywords provided by Hospital Israelita Albert Einstein:
bone marrow transplantation
graft versus host disease
Acute myelogenous leukemia
Acute lymphoid leukemia
Myeloproliferative disease
Myelodysplastic syndrome
Chronic myeloid leukemia
chronic myelomonocytic leukemia

Additional relevant MeSH terms:
Graft vs Host Disease
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myelomonocytic, Acute
Myeloproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Myelodysplastic-Myeloproliferative Diseases
Precancerous Conditions
Cyclophosphamide
Methotrexate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014