GVHD Prophylaxis With Methotrexate in Haploidentical HCT Using Posttransplant Cyclophosphamide

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Nov 9, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a medication called methotrexate (MTX) to see if it can help prevent graft-versus-host disease (GVHD) in patients receiving a type of stem cell transplant known as haploidentical hematopoietic cell transplantation (HCT). GVHD is a serious condition where the transplanted cells attack the patient’s body, and finding effective ways to prevent it is crucial for improving patient outcomes. The trial aims to compare the effectiveness and safety of methotrexate to other common preventive treatments used in Brazil.

To participate in this trial, patients must be adults aged 18 to 75 and have specific types of blood cancers or conditions in remission. They need to have a haploidentical related donor, which means a family member who is a partial match. Participants will receive methotrexate along with standard post-transplant treatment, and researchers will monitor their health closely. It’s important to note that certain medical conditions or treatments may exclude individuals from joining the trial, so potential participants will be carefully evaluated for eligibility. This study could provide valuable insights into improving care for patients undergoing this type of transplant.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 remission
• • Donor type: haploidentical related donor
• • Graft source: bone marrow or peripheral blood
• • Recipients of non-myeloblative or myeloablative intensity conditioning
• • Left Ventricle Ejection fraction \> 40%
• • Estimated creatinine clearance \> 40 mL/min
• • Adjusted DLCO ≥ 40% and FEV1 ≥ 40%
• • Total bilirubin \< 2x ULN e ALT/AST \< 2.5x ULN
• Exclusion Criteria:
• • Prior allogeneic transplant
• • Ex-vivo graft manipulation (T-cell-depleted or CD34-selected grafts)
• • Use of alemtuzumab or anti-thymocyte globulin
• • KPS \< 70%
• • Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment
• • Pregnant or lactating women
• • Patients seropositive for human immunodeficiency virus (HIV) or active hepatitis B or C infection by PCR
• • Presence of fluid collection (ascites, pleural or pericardial effusion) that may interfere with methotrexate clearance or make methotrexate use contraindicated
• • Patients with a serious medical or psychiatric illness likely to interfere with participation in this study