Radioimmunotherapy Conditioning With 131I- Apamistamab for Allogeneic Transplant in Relapse/Refractory AML (RADAR)

Launched by ACTINIUM PHARMACEUTICALS ·

Keywords

ClinConnect Summary

This trial is testing a new way to prepare the body for an allogeneic stem cell transplant in adults with relapsed or refractory acute myeloid leukemia (AML). In Phase 2, researchers will test three different radiation doses of a radioactive antibody therapy (131I-apamistamab) given with chemotherapy (fludarabine) and low-dose whole-body radiation to find the safest and most effective dose. In Phase 3, participants are randomly assigned to receive either this new conditioning approach or the standard conditioning before transplant, to see if the new method helps people live longer.

Who might be eligible? Adults age 18 and older with active, relapsed, or refractory AML and 5–20% leukemia cells in the bone marrow, with a CD45 marker on the leukemia cells, and who have a matched donor (8/8). They must not be suitable for high-intensity conditioning, have adequate kidney and liver function, a reasonable overall health status, and no active central nervous system leukemia or other exclusionary conditions. Exclusions include more than 20% marrow blasts, prior stem cell transplant, significant heart disease, certain infections, or other active cancers in the past two years. If enrolled, you would go through screening tests, then receive the assigned conditioning regimen before transplant, with ongoing safety follow-up for up to 5 years. The study is sponsored by Actinium Pharmaceuticals and is FDA-regulated; enrollment is planned to begin around January 2026, with completion anticipated in 2034. Primary goal is to see whether the new approach improves overall survival after transplant, with several secondary measures including remission rates and safety.

Gender

ALL

Eligibility criteria