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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

Study Description
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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

Condition or disease Intervention/treatment 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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

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Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749111


Locations
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Brazil
Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)
São Paulo, Brazil, 05652-000
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Investigators
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Principal Investigator: Paulo V Campregher, MD Hospital Israelita Albert Einstein
More Information
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Publications:

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Responsible Party: Paulo Vidal Campregher, MD, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT01749111    
Other Study ID Numbers: GEDECH-2012
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Keywords provided by Paulo Vidal Campregher, 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:
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Leukemia
Leukemia, Myeloid
Preleukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myelomonocytic, Chronic
Leukemia, Myeloid, Acute
Leukemia, Myelomonocytic, Juvenile
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Myeloproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
 Precancerous Conditions
Immune System Diseases
Myelodysplastic-Myeloproliferative Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Cyclophosphamide
Methotrexate
Calcineurin Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents