Brief Summary
The purpose of this study is to evaluate the safety, tolerability and determine the recommended dosethe amount of medication taken for further clinical evaluation of ELVN-001 in patients with chronica long-lasting disease that changes slowly over time myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.
Intervention / Treatment
- Drug: ELVN-001
Inclusion Criteria
- BCR-ABL1 positive CML in chronic phase, with or without T315I mutation.
- The patient has failed, is intolerant to, or not a candidate for, available therapies known to be active for treatment of their CML.
- ECOG performance status of 0 to 2.
- Adequate hematologic, hepatic and renal function.
- Prior bone marrow transplanta procedure that involves replacing unhealthy bone marrow with healthy bone marrow allowed if ≥ 6 months prior to the first dose of ELVN-001.