Phase II Study of Haploidentical Donor Stem Cell Transplant Using Treosulfan, Fludarabine, and Total-Body Irradiation for Blood Cancers

What this Trial Is About

Researchers are studying how well a donor stem cell transplant combined with chemotherapy drugs treosulfan and fludarabine, plus total-body irradiation, works in treating patients with various blood cancers. This phase II trial aims to understand the effects of these treatments on stopping cancer growth and supporting the bone marrow to produce healthy blood and immune cells after transplant. The study focuses on patients with hematological malignancies, including leukemia and lymphoma, and is sponsored by Fred Hutchinson Cancer Center. Participants are assigned to one of two groups one receives a high dose of treosulfan intravenously over three days, while the other receives a lower dose over the same period. Both groups receive fludarabine intravenously for five days, total-body irradiation, and a donor stem cell transplant. After the transplant, patients receive additional medications, including cyclophosphamide, cyclosporine, mycophenolate sodium or mofetil, and filgrastim to support immune recovery and prevent complications. Treatments are carefully timed before and after the transplant, with specific dosing schedules outlined for each medication. During the study, patients undergo various assessments such as bone marrow aspiration and biopsy, echocardiography, blood sample collection, and imaging scans like CT or PETCT. Follow-up visits occur at multiple time points up to two years post-transplant to monitor graft success, survival, disease progression, and complications like graft-versus-host disease and infections. Researchers also track platelet recovery and overall health to evaluate the treatments effects and safety over time.

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies