Phase 12 Study of Decitabine Combined With FLAG-Ida Chemotherapy and Total Body Irradiation Followed by Donor Stem Cell Transplant in Adults With High-Risk Myeloid Blood Cancers

What this Trial Is About

Researchers are evaluating the safety, side effects, and optimal dose of decitabine combined with a chemotherapy regimen called FLAG-Ida and total body irradiation TBI, followed by a donor stem cell transplant in adults with certain blood cancers. These cancers include acute myeloid leukemia AML, myelodysplastic syndrome MDS, and chronic myelomonocytic leukemia CMML that have a high risk of returning after treatment. Decitabine is a medication that helps the bone marrow produce normal blood cells and targets abnormal cells. The study aims to see if adding decitabine improves treatment compared to FLAG-Ida and TBI alone. Participants receive decitabine intravenously daily over one hour for varying days before transplant, along with filgrastim injections, idarubicin, fludarabine, and cytarabine infusions, followed by total body irradiation given either twice daily or once daily just before receiving donor peripheral blood stem cells PBSCs via infusion on day 0. Donors undergo apheresis to collect PBSCs. The treatment involves a phase I dose-escalation followed by a phase II study. During the study, patients undergo heart scans MUGA or echocardiography, chest X-rays, bone marrow biopsies, and blood sample collections. Follow-up visits occur at 6 months, 1 year, and 2 years after treatment to monitor outcomes such as survival without disease return and transplant-related complications. The study measures include disease-free survival at 1 year and non-relapse mortality at day 100.

Chemotherapy (Decitabine in Combination With FLAG-Ida) and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Adults With Myeloid Malignancies at High Risk of Relapse