Clinical trial NCT01749111: Comparison Between Cyclophosphamide and Combination of Methotrexate + Calcineurin Inhibitor for GVHD Prophylaxis
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Myelogenous Leukemia
Acute Lymphoid Leukemia
Myeloproliferative Disease
Myelodysplastic Syndrome
Chronic Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Keywords: bone marrow transplantation
graft versus host disease
Acute myelogenous leukemia
Acute lymphoid leukemia
Myeloproliferative disease
Myelodysplastic syndrome
Chronic myeloid leukemia
chronic myelomonocytic leukemia
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2012-12-13
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
timeFrame: one year
Secondary outcomes:
measure: Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation
timeFrame: one year
Other outcomes:
measure: Cumulative incidence of disease relapse, one year after bone marrow transplantation
timeFrame: one year
Locations:
city: São Paulo
country: Brazil
facility: Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Paulo V Campregher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luznik L, Bolanos-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.