Using Methotrexate to Prevent Graft Versus Host Disease in Haploidentical Bone Marrow Transplants
GVHD Prophylaxis With Methotrexate and Cyclosporine in Haploidentical Stem Cell Transplantation Using Posttransplant Cyclophosphamide in Hematologic Malignancies: Phase I/II Trial
This study is testing if using methotrexate can help prevent graft-versus-host disease in patients receiving bone marrow transplants from partially matched donors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 47 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Drugs / interventions | alemtuzumab, methotrexate, cyclophosphamide |
| Locations | 4 sites (Rio De Janeiro, RJ and 3 other locations) |
| Trial ID | NCT04622956 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of methotrexate as a prophylactic treatment to prevent graft-versus-host disease (GVHD) in patients undergoing haploidentical hematopoietic cell transplantation (HCT). The study compares methotrexate with the commonly used combination of posttransplant cyclophosphamide and cyclosporine. Patients with specific hematologic malignancies who have a haploidentical donor will be enrolled, and their outcomes will be monitored to assess the effectiveness of methotrexate in reducing GVHD incidence. The trial aims to provide insights into the optimal GVHD prophylaxis strategy in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study include patients with specific hematologic malignancies in remission who have a haploidentical related donor.
Not a fit: Patients who have previously undergone allogeneic transplants or have uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of GVHD and improve long-term outcomes for patients undergoing haploidentical HCT.
How similar studies have performed: Previous studies have shown mixed results regarding the use of methotrexate for GVHD prophylaxis, indicating that while some approaches have been successful, this specific application in haploidentical HCT is still being explored.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rio De Janeiro, RJ and 3 other locations
- Instituto Nacional de Câncer José Alencar Gomes Da Silva - Inca — Rio De Janeiro, Rj, Brazil (Recruiting)
- Centro de Hematologia e Hemoterapia - HEMOCENTRO — Campinas, São Paulo, Brazil (Recruiting)
- Hospital Amaral Carvalho / Fundação Dr. Amaral Carvalho — Jaú, São Paulo, Brazil (Recruiting)
- Hospital das Clinicas da Universidade de Sao Paulo — Sao Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Giancarlo Fatobene, MD — Hospital das Clínicas da Universidade de São Paulo
- Study coordinator: Giancarlo Fatobene, MD
- Email: gian_fatobene@hotmail.com
- Phone: +551126617575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.