NCT07905183Not yet recruitingPhase 3
A Randomized Study of ELVN-001 Versus Investigator-Selected TKI, in CP-CML Previously Treated With One or More TKIs
A Phase 3, Multicenter, Open-Label, Randomized Study of ELVN-001 Versus Investigator-Selected Tyrosine Kinase Inhibitor (TKI) of Dasatinib, Nilotinib, or Bosutinib, in Adult Participants With Chronic Myeloid Leukemia in Chronic Phase (CP-CML), Previously Treated With One or More TKIs
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- First submitted
- 23 Oct 2026
- Start date
- 31 Dec 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Enliven Therapeutics
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT07905183
- EU CT number
- 2026-526266-25-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 450
- From 31 Dec 2026 to the primary completion date, 31 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known second chronic phase of CML after previous progression to accelerated or blast phase
- Previous treatment with a hematopoietic stem-cell transplantation
Other illness
- Any serious or uncontrolled medical disorder
Lab values
- QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec
Other
- Known T315I mutation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.