Comparison Between Cyclophosphamide and Combination of Methotrexate + Calcineurin Inhibitor for GVHD Prophylaxis (CICLODECH)
This study is currently recruiting participants.
Verified December 2012 by Hospital Israelita Albert Einstein
Sponsor:
Hospital Israelita Albert Einstein
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
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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:
MedlinePlus related topics:
Acute Myeloid Leukemia
Bone Marrow Transplantation
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Leukemia
Myelodysplastic Syndromes
U.S. FDA Resources
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
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 May 19, 2013