A Randomized Study of ELVN-001 Versus Investigator-Selected TKI, in CP-CML Previously Treated With One or More TKIs
Run by Enliven Therapeutics · NCT07905183 · Data updated 2026-11-12
Not yet open. This study is not taking new participants. Its registered completion date is 2028-12-31.
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.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | Enliven Therapeutics Industry-sponsored |
| Drugs / interventions | ELVN-001, TKI |
| Trial ID | NCT07905183 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, open-label, randomized study of ELVN-001 versus Investigator-selected TKI (Dasatinib, Nilotinib, or Bosutinib) in adult participants with CP-CML previously treated with one or more TKIs. Participants will be randomized to receive either ELVN-001 or their investigator's choice of one of the comparator TKIs (Dasatinib, Nilotinib, or Bosutinib). Treatment will continue until one of the protocol defined treatment discontinuation criteria are met. Participants will then enter a long-term follow-up period for survivorship and updates on disease status.
Who can join: the full rules
Show full inclusion / exclusion 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
Study contacts
- Study coordinator: Enliven Medical Information
- Email: MedInfo@enliventherapeutics.com
- Phone: +1 6505475814
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.