A Randomized Study of ELVN-001 Versus Investigator-Selected TKI, in CP-CML Previously Treated With One or More TKIs

Conditions: Chronic Myeloid Leukemia (CML), Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive, Chronic Phase Chronic Myeloid Leukemia, BCR::ABL1 Positive CML

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE3

Enrollment: 450

Sponsor: Enliven Therapeutics

Summary

The study is designed to compare the efficacy of ELVN-001 versus Investigator-selected tyrosine kinase inhibitor (TKI) for adults with previously treated chronic myeloid leukemia in the chronic phase (CP-CML). The Investigator-selected TKI will be one of the following standard of care therapies: Dasatinib, Nilotinib, or Bosutinib.

Eligibility Criteria

Inclusion Criteria: * Male or female at least 18 years of age * Diagnosis of chronic myeloid leukemia in chronic phase (CP-CML) * Prior treatment with 1 or more BCR::ABL1 TKI(s) * Failure or intolerance on the immediate prior TKI * Adequate end organ function as measured by blood tests Exclusion Criteria: * Known T315I mutation * Known second chronic phase of CML after previous progression to accelerated or blast phase * Any serious or uncontrolled medical disorder * QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec * Previous treatment with a hematopoietic stem-cell transplantation

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07905183). StuddyBuddy aggregates publicly available trial information.