Intensity Modulated Total Marrow Irradiation in Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), and Myelodysplastic Syndrome (MDS)

Phase 2 Recruiting 38 enrolled University of Illinois at Chicago

NaSingle-groupOpen-labelTreatment

Summary

The study is a Phase II clinical trial. Patients will receive intensity-modulated total marrow irradiation (TMI) at a dose of 9 Gray (Gy) with standard myeloablative fludarabine intravenous (IV) and targeted busulfan (FluBu4) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT). Graft-versus-host disease (GVHD) prophylaxis will include Cyclophosphamide on Day +3 and +4, tacrolimus, and mycophenolate mofetil.

Timeline

Start: 2025-02-04
Primary completion: 2030-03
Completion: 2032-03

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Busulfan	Small molecule	4800 unknown	Intravenous
Subject	Cyclophosphamide	Other / unclassified	50 mg/kg	—
Subject	Fludarabine	Small molecule	40 mg/m2	Intravenous

Intensity Modulated Total Marrow Irradiation in Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), and Myelodysplastic Syndrome (MDS)

Summary

Timeline

Drugs

Indications