Last updated 3 years ago
GVHD Prophylaxis With Methotrexate in Haploidentical HCT Using Posttransplant Cyclophosphamide
47 patients around the world
Available in Brazil
University of Sao Paulo General Hospital
3Research sites
47Patients around the world
Requirements for the patient
To 70 Years
All Gender
Medical requirements
- Diagnosis of acute myeloid leukemia and chronic myeloid leukemia in complete morphologic remission, myelodysplastic syndrome with less than 10% in bone marrow or peripheral blood, Ph-negative acute lymphoblastic leukemia in complete morphologic remission, chemosensitive Hodgkin lymphoma or non-Hodgkin lymphoma in at least partial remissionDonor type: haploidentical related donorGraft source: bone marrow or peripheral bloodRecipients of non-myeloblative or myeloablative intensity conditioningLeft Ventricle Ejection fraction > 40%Estimated creatinine clearance > 40 mL/minAdjusted DLCO ≥ 40% and FEV1 ≥ 40%Total bilirubin < 2x ULN e ALT/AST < 2.5x ULN
- Prior allogeneic transplantEx-vivo graft manipulation (T-cell-depleted or CD34-selected grafts)Use of alemtuzumab or anti-thymocyte globulinKPS < 70%Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollmentPregnant or lactating womenPatients seropositive for human immunodeficiency virus (HIV) or active hepatitis B or C infection by PCRPresence of fluid collection (ascites, pleural or pericardial effusion) that may interfere with methotrexate clearance or make methotrexate use contraindicatedPatients with a serious medical or psychiatric illness likely to interfere with participation in this study
Sites
Hospital das Clínicas da Faculdade de Medicina da São Paulo - USP
Recruiting
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Recruiting
Hospital Amaral Carvalho
Recruiting
SponsorUniversity of Sao Paulo General Hospital
Study typeInterventional
Requirements
To 70 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04622956
