A Phase 3 interventional study of ELVN-001 and TKI in Chronic Myeloid Leukemia (CML), Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive and Chronic Phase Chronic Myeloid Leukemia, BCR::ABL1 Positive CML, sponsored by Enliven Therapeutics. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Enliven Therapeutics · Phase 3, Interventional, and Treatment
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.
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.
894 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.
This study's planned enrollment of 450 is above the median of 44 across 681 interventional studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →Enliven Therapeutics is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ELVN-001
Drug: ELVN-001
Randomized to receive one of the following investigator's choice TKIs: Dasatinib, Nilotinib, or Bosutinib
Drug: TKI
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.
Time frame: 24 weeks
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.
Time frame: 96 weeks
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.
Time frame: planned total follow-up duration of 5 years
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
Time frame: planned total follow-up duration of 5 years
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
Time frame: planned total follow-up duration of 5 years
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
Time frame: planned total follow-up duration of 5 years
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
Time frame: planned total follow-up duration of 5 years
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
Time frame: planned total follow-up duration of 5 years
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
Time frame: planned total follow-up duration of 5 years
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
Time frame: planned total follow-up duration of 5 years
Overall survival (OS) - ELVN-001 versus Investigator-selected TKI
OS is defined as the time from randomization to death from any cause
Time frame: planned total follow-up duration of 5 years
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
Time frame: planned total follow-up duration of 5 years
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
Time frame: planned total follow-up duration of 5 years
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
Time frame: planned total follow-up duration of 5 years
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
Time frame: planned total follow-up duration of 5 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive →
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