Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes

Phase 2 Active not 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 Gy with standard myeloablative fludarabine/ i.v. targeted busulfan (FluBu) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT).

Timeline

Start: 2017-04-24
Primary completion: 2026-04
Completion: 2026-04

Publications

Maahs L, Avila AM, Koshy M, Sweiss K, Ahn KH, Chen Z, Uzoka C, Galvez C, Sanchez M, Rubinstein P, Quigley J, Zucchetti E, Mahmud N, Aydogan B, Patel P, Rondelli D. Intensified conditioning with high-dose total marrow irradiation and myeloablative chemotherapy reduces risk of relapse without increasing toxicity in allogeneic hematopoietic stem cell transplant for high-risk myeloid malignancies: a phase II study. Haematologica. 2026 Jan 1;111(1):177-183. doi: 10.3324/haematol.2025.287457. Epub 2025 Jun 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	ATG	Protein / enzyme biologic	2 mg/kg	Intravenous
Background	Busulfan	Small molecule	4800 unknown	Intravenous
Background	Fludarabine	Small molecule	40 mg/m2	Intravenous
Background	Methotrexate	Small molecule	5 mg/m2	—
Background	Tacrolimus	Small molecule	0.03 mg/kg	Intravenous

Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes

Summary

Timeline

Publications

Drugs

Indications