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

Myelodysplastic Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01749111
• Other study ID #: GEDECH-2012
• Status: Terminated
• Phase: Phase 3
• First received: December 11, 2012
• Last updated: March 2, 2017
• Start date: December 2012
• Est. completion date: August 2016

Study information

• Verified date: March 2017
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphoid Leukemia
• Acute Myelogenous Leukemia
• Chronic Myeloid Leukemia
• Chronic Myelomonocytic Leukemia
• Graft vs Host Disease
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Myelomonocytic, Acute
• Leukemia, Myelomonocytic, Chronic
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Myeloproliferative Disease
• Myeloproliferative Disorders
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia

Intervention

Drug:
• ARM A Cyclophosphamide
Cyclophosphamide 50 mg/kg on day+3 and day+4 after bone marrow transplantation
• 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

Locations

Country	Name	City	State
Brazil	Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cumulative incidence of disease relapse, one year after bone marrow transplantation	Cumulative incidence of disease relapse, one year after bone marrow transplantation	one year
Primary	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.	one year
Secondary	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	one year