IMRT-TMI With Fludarabine as Myeloablative Conditioning for Allogeneic HSCT

Summary

This is a phase I/II clinical trial on the use of total marrow irradiation (TMI) given concurrently with fludarabine, a chemotherapy drug commonly used to treat leukemia, as a myeloablative therapy for patients undergoing Allo-HSCT. TMI is a targeted technique to deliver radiation to the bone marrow while minimizing dose to other normal organs in the body. In phase I of the clinical study, the dose of radiation to the bone marrow will be incrementally increased to determine the highest tolerated TMI dose. In phase II, the effectiveness of the TMI-fludarabine conditioning regimen utilizing that dose of radiation will be studied. Acute and long-term toxicity data as well as quality of life data will also be studied. \*Stopping criteria was met during the first dose level cohort in Phase l. The trial will not continue into Phase II as originally planned.

Timeline

Start

2018-08-29

Primary completion

2020-07-08

Completion

2021-04-13

Outcome

Outcome not reported

Stopped: “Extreme toxicity”

Drugs

Indications