Trial · NCT07905183
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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 |
| Secondary | Overall survival (OS) - ELVN-001 versus Investigator-selected TKI | planned total follow-up duration of 5 years | OS is defined as the time from randomization to death from any cause |
| Secondary | MR4 and MR4.5 at and by all scheduled data 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). 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 |
| Secondary | Time to treatment discontinuation due to adverse event (AE) - ELVN-001 versus Investigator-selected TKI | planned total follow-up duration of 5 years | This is defined as the time from randomization to discontinuation of study treatment due to an adverse event |
| Secondary | 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 | planned total follow-up duration of 5 years | Characteristics of AEs will be evaluated to assess safety and tolerability profiles |
| Secondary | Plasma concentrations of ELVN-001 in participants treated with ELVN-001 will be assessed at all scheduled collection timepoints | planned total follow-up duration of 5 years | Relevant pharmacokinetic parameters will be evaluated |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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