IMRT-TMI With Fludarabine as Myeloablative Conditioning for Allogeneic HSCT
Status:
Active, not recruiting
Trial end date:
2022-05-12
Target enrollment:
Participant gender:
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.