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Chronic Myeloid Leukemia (CML)Phase 3ENABLE-2NCT07905183

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

A Phase 3 study testing ELVN-001 and TKI in people with Chronic Myeloid Leukemia (CML) and Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive, run by Enliven Therapeutics.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ELVN-001 and TKI
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
No sites listed yet
Study dates
31 Dec 2026to Jul 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Enliven Medical Information contact

+1 6505475814

MedInfo@enliventherapeutics.com

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
ELVN-001, TKI
Keywords
Chronic Myeloid Leukemia, CML, ELVN-001, Philadelphia chromosome, Tyrosine kinase inhibitor, TKI, TKIs, ENABLE-2, Bosutinib, Dasatinib, Nilotinib, Molecular Response, BCR::ABL, Active site inhibitor of BCR::ABL
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase, Philadelphia Chromosome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ELVN-001Drug

    ELVN-001 orally daily

  • TKIDrug

    Also called Dasatinib, Nilotinib, Bosutinib

    TKI orally daily

Study groups in NCT07905183
Study groupRoleWhat they receive
ELVN-001ExperimentalELVN-001
Receives: Drug: ELVN-001
Investigator-selected TKIActive comparatorRandomized to receive one of the following investigator's choice TKIs: Dasatinib, Nilotinib, or Bosutinib
Receives: Drug: TKI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Molecular Response (MMR) Rate at Week 24 - ELVN-001 versus Investigator-selected TKI

    Molecular response is assessed using BCR::ABL1 transcript levels measured by quantitative polymerase chain reaction (qPCR). MMR is defined as a ratio BCR::ABL/ABL1 ≤ 0.1% on the International Scale.

    Measured: 24 weeks

Secondary outcomes (14)

  1. Major Molecular Response (MMR) Rate at Week 96 - ELVN-001 versus Investigator-selected TKI

    Molecular response is assessed using BCR::ABL1 transcript levels measured by quantitative polymerase chain reaction (qPCR). MMR is defined as a ratio BCR::ABL/ABL1 ≤ 0.1% on the International Scale.

    Measured: 96 weeks

  2. Change in overall scores, individual scales, and health status based on participant reporting - ELVN-001 versus Investigator-selected TKI

    Validated questionnaires will be used to assess disease-related symptoms, functioning, and tolerability.

    Measured: planned total follow-up duration of 5 years

  3. Major Molecular Response (MMR) at all scheduled collection time points - ELVN-001 versus Investigator-selected TKI

    Molecular response is assessed using BCR::ABL1 transcript levels measured by quantitative polymerase chain reaction (qPCR). MMR is defined as a ratio BCR::ABL/ABL1 ≤ 0.1% on the International Scale

    Measured: planned total follow-up duration of 5 years

  4. Major Molecular Response (MMR) by all scheduled collection time points - ELVN-001 versus Investigator-selected TKI

    Molecular response is assessed using BCR::ABL1 transcript levels measured by quantitative polymerase chain reaction (qPCR). MMR is defined as a ratio BCR::ABL/ABL1 ≤ 0.1% on the International Scale

    Measured: planned total follow-up duration of 5 years

  5. Time to Major Molecular Response (MMR) - ELVN-001 versus Investigator-selected TKI

    The time to MMR is defined as the time from the date of randomization to the date of the first documented occurrence of MMR

    Measured: planned total follow-up duration of 5 years

  6. Duration of Major Molecular Response (MMR) - ELVN-001 versus Investigator-selected TKI

    Duration of MMR is defined as the time between the date of the first achievement of MMR and the earliest date of loss of MMR or CML-related death

    Measured: planned total follow-up duration of 5 years

  7. BCR::ABL1 ratio ≤ 1% at and by all scheduled data collection time points - ELVN-001 versus Investigator-selected TKI

    BCR::ABL1 transcript levels are measured by quantitative polymerase chain reaction (qPCR). The ratio is calculated for BCR::ABL/ABL1 based on the International Scale

    Measured: planned total follow-up duration of 5 years

  8. Time to treatment failure - ELVN-001 versus Investigator-selected TKI

    Time to treatment failure is defined as the time from randomization to the first date of any of the following events: treatment failure as defined per protocol

    Measured: planned total follow-up duration of 5 years

  9. Progression-free survival - ELVN-001 versus Investigator-selected TKI

    Progression-free survival is defined as the time from randomization to the earliest occurrence of progression or death from any cause

    Measured: planned total follow-up duration of 5 years

  10. Overall survival (OS) - ELVN-001 versus Investigator-selected TKI

    OS is defined as the time from randomization to death from any cause

    Measured: planned total follow-up duration of 5 years

  11. MR4 and MR4.5 at and by all scheduled data collection time points - ELVN-001 versus Investigator-selected TKI

    Molecular response is assessed using BCR::ABL1 transcript levels measured by quantitative polymerase chain reaction (qPCR). MR4 is defined as a ratio BCR::ABL/ABL1 ≤ 0.01% on the International Scale and MR4.5 is defined as a ratio BCR::ABL/ABL1 ≤ 0.0032% on the International Scale

    Measured: planned total follow-up duration of 5 years

  12. Time to treatment discontinuation due to adverse event (AE) - ELVN-001 versus Investigator-selected TKI

    This is defined as the time from randomization to discontinuation of study treatment due to an adverse event

    Measured: planned total follow-up duration of 5 years

  13. Characterization of adverse events (AE) and clinically relevant findings, including laboratory abnormalities, electrocardiogram (ECG) changes, and other safety data - ELVN-001 versus Investigator-selected TKI

    Characteristics of AEs will be evaluated to assess safety and tolerability profiles

    Measured: planned total follow-up duration of 5 years

  14. Plasma concentrations of ELVN-001 in participants treated with ELVN-001 will be assessed at all scheduled collection timepoints

    Relevant pharmacokinetic parameters will be evaluated

    Measured: planned total follow-up duration of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start31 Dec 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completionJul 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07905183
Sponsor's protocol ID
ELVN-001-301
Other IDs
2026-526266-25-00
Acronym
ENABLE-2
Status last verified
Oct 2026
First submitted
23 Oct 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ELVN-001 and TKI in people with Chronic Myeloid Leukemia (CML) and Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive, run by Enliven Therapeutics.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Enliven Medical Information (+1 6505475814, MedInfo@enliventherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Molecular Response (MMR) Rate at Week 24 - ELVN-001 versus Investigator-selected TKI (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07905183.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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