Phase 1 Study of CLAG-M or FLAG-Ida Chemotherapy with Reduced-Intensity Conditioning and Donor Stem Cell Transplant for Adults with Relapsed or Refractory Myeloid Blood Cancers

What this Trial Is About

Researchers are evaluating the best dose of total body irradiation combined with two chemotherapy regimens, CLAG-M or FLAG-Ida, as part of a reduced-intensity conditioning before donor stem cell transplant in adults with relapsed or refractory acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia. This phase I trial aims to find the optimal treatment combination to prepare the body for stem cell transplant, which may help replace unhealthy bone marrow and fight remaining cancer cells. The study also monitors prevention of graft versus host disease using specific medications after transplant. The study has two treatment arms. In Arm I, patients receive filgrastim, cladribine, cytarabine, and mitoxantrone chemotherapy over several days before undergoing total body irradiation and hematopoietic cell transplantation. In Arm II, patients receive filgrastim, fludarabine, cytarabine, and idarubicin chemotherapy with similar timing, followed by irradiation and transplant. Both arms include graft versus host disease prevention with cyclophosphamide, cyclosporine, and mycophenolate mofetil given on scheduled days after transplant. Patients receiving unrelated cord blood transplants follow a specific medication schedule. Participants undergo heart scans MUGA or echocardiography, x-rays, bone marrow biopsies, and blood sample collections during screening and at multiple points up to one year post-transplant. After completing treatment, follow-up visits occur at 100 days, then 6, 12, and 24 months to monitor transplant success, disease progression, and any complications. Researchers measure rates of transplant failure, disease progression, graft versus host disease, adverse events, and remission duration throughout the study.

CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia