Trial · NCT07905183
A Randomized Study of ELVN-001 Versus Investigator-Selected TKI, in CP-CML Previously Treated With One or More TKIs
NCT07905183, Phase 3, Not yet recruiting, Enliven Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized Study of ELVN-001 Versus Investigator-Selected TKI, in CP-CML Previously Treated With One or More TKIs. Trials, record NCT07905183. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07905183
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Study of ELVN-001 Versus Investigator-Selected TKI, in CP-CML Previously Treated With One or More TKIs
- NCT number
- NCT07905183
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 450 participants, estimated
- Lead sponsor
- Enliven Therapeutics
- Conditions
- Chronic Myeloid Leukemia (CML), Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive, Chronic Phase Chronic Myeloid Leukemia, BCR::ABL1 Positive CML
- Interventions
- ELVN-001, TKI
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Major Molecular Response (MMR) Rate at Week 24 - ELVN-001 versus Investigator-selected TKI | 24 weeks | 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. |
| Secondary | Major Molecular Response (MMR) Rate at Week 96 - ELVN-001 versus Investigator-selected TKI | 96 weeks | 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. |
| Secondary | Change in overall scores, individual scales, and health status based on participant reporting - ELVN-001 versus Investigator-selected TKI | planned total follow-up duration of 5 years | Validated questionnaires will be used to assess disease-related symptoms, functioning, and tolerability. |
| Secondary | Major Molecular Response (MMR) at all scheduled collection time points - ELVN-001 versus Investigator-selected TKI | planned total follow-up duration of 5 years | 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 |
| Secondary | Major Molecular Response (MMR) by all scheduled collection time points - ELVN-001 versus Investigator-selected TKI | planned total follow-up duration of 5 years | 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 |
| Secondary | Time to Major Molecular Response (MMR) - ELVN-001 versus Investigator-selected TKI | planned total follow-up duration of 5 years | The time to MMR is defined as the time from the date of randomization to the date of the first documented occurrence of MMR |
| Secondary | Duration of Major Molecular Response (MMR) - ELVN-001 versus Investigator-selected TKI | planned total follow-up duration of 5 years | 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 |
| Secondary | BCR::ABL1 ratio ≤ 1% at and by all scheduled data collection time points - ELVN-001 versus Investigator-selected TKI | planned total follow-up duration of 5 years | 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 |
| Secondary | Time to treatment failure - ELVN-001 versus Investigator-selected TKI | planned total follow-up duration of 5 years | 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 |
| Secondary | Progression-free survival - ELVN-001 versus Investigator-selected TKI | planned total follow-up duration of 5 years | Progression-free survival is defined as the time from randomization to the earliest occurrence of progression or death from any cause |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07905183
GET https://conductscience.org/api/trials/v1/NCT07905183/registered