Trial · NCT03106779
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Major Molecular Response (MMR) Rate at 24 Weeks | 24 weeks | MMR was defined as a ≥ 3.0 log reduction in BCR-ABL1 transcripts compared to the standardized baseline equivalent to ≤ 0.1% BCR-ABL1/ABL% by international scale (IS) as measured by RQ-PCR. |
| Secondary | Major Molecular Response (MMR) Rate at 96 Weeks (Key Secondary Endpoint) | 96 Weeks | MMR at 96 weeks was defined as the percentage of participants with MMR at 96 weeks. MMR was defined as a ≥ 3.0 log reduction in BCR-ABL1 transcripts compared to the standardized baseline equivalent to ≤ 0.1% BCR-ABL1/ABL% by international scale (IS) as measured by RQ-PCR. |
| Secondary | Complete Cytogenetic Response (CCyR) Rate at Scheduled Time Points | at 24, 48, 72, 96, 120 and 144 weeks | Cytogenic response included Complete, Partial, Major, Minor, Minimal and no response. Cytogenetic response was assessed as the percentage of Ph+ metaphases in the bone marrow and is defined as the following: Complete (CCyR) - 0% Ph+ metaphases; Partial (PCyR) - \>0 to 35% Ph+ metaphases; Major (MCyR) - 0 to 35% Ph+ metaphases; Minor (mCyR) - \>35 to 65% Ph+ metaphases; Minimal - \>65 to 95% Ph+ metaphases; None - \>95 to 100% Ph+ metaphases. |
| Secondary | Complete Cytogenetic Response Rate by Scheduled Time Points | by 24, 48, 72, 96, 120 and 144 weeks | Cytogenic response included Complete, Partial, Major, Minor, Minimal and no response. Cytogenetic response was assessed as the percentage of Ph+ metaphases in the bone marrow and is defined as the following: Complete (CCyR) - 0% Ph+ metaphases; Partial (PCyR) - \>0 to 35% Ph+ metaphases; Major (MCyR) - 0 to 35% Ph+ metaphases; Minor (mCyR) - \>35 to 65% Ph+ metaphases; Minimal - \>65 to 95% Ph+ metaphases; None - \>95 to 100% Ph+ metaphases. |
| Secondary | Major Molecular Response (MMR) Rate at All Scheduled Data Collection Time Points Except Weeks 24 & 96 | at Weeks 36, 48, 60, 72, 84, 108, 120, 132, 144 & 156 | MMR was defined as a ≥ 3.0 log reduction in BCR-ABL1 transcripts compared to the standardized baseline equivalent to ≤ 0.1% BCR-ABL1/ABL% by international scale (IS) as measured by RQ-PCR. |
| Secondary | Major Molecular Response (MMR) Rate by All Scheduled Data Collection Time Points | by Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 & 156, Overall | MMR was defined as a ≥ 3.0 log reduction in BCR-ABL1 transcripts compared to the standardized baseline equivalent to ≤ 0.1% BCR-ABL1/ABL% by international scale (IS) as measured by RQ-PCR. Overall time point has the count indicating participants achieving MMR at any time during the study. |
| Secondary | Time to Major Molecular Response (MMR) | 216 Weeks | Time to MMR was defined as the time from the date of randomization to the date of the first documented MMR. |
| Secondary | Duration of Major Molecular Response (MMR) | 216 Weeks | Duration of MMR was defined as the time from the date of first documented MMR to the earliest date of loss of MMR, progression to Accelerated phase (AP) or Blast crisis (BC), or Chronic myeloid leukemia (CML)-related death. |
| Secondary | Time to Complete Cytogenetic Response Rate (CCyR) Among Participants Who Achieved CCyR | 216 Weeks | Time to CCyR was defined as the time from the date of randomization to the date of the first documented CCyR. |
| Secondary | Duration of Complete Cytogenetic Response (CCyR) | 144 weeks | Duration of CCyR was defined as the time between date of first documented CCyR and the earliest date of loss of CCyR, progression to AP/BC, or CML-related death for participants in the Cytogenetic Responder Set. The time was censored at the last cytogenetic assessment date on treatment for participants for whom none of the events was reported or last PCR evaluation on treatment indicating MMR. |
| Secondary | Time to Treatment Failure (TTF) | From the first dose of treatment up to 5 years, through treatment completion, an average of 2.3 years, approximately | TTF was defined as the time from date of randomization to an event of treatment failure. Treatment failure was defined as meeting a lack of efficacy criterion or discontinuing treatment due to any reason. |
| Secondary | Progression Free Survival Per Percentage Event-free Kaplan-Meier Estimates | From the first dose of treatment up to study completion, up to 5 years | Progression-free survival was defined as the time from the date of randomization to the earliest occurrence of documented disease progression to AP/BC or the date of death from any cause (including progressions and deaths observed during the survival follow-up period), per Kaplan-Meier. |
| Secondary | Overall Survival (OS) Per Event Free Percentage Per Kaplan-Meier Estimates | From the first dose of treatment to study completion, up to 5 years | Overall survival is defined as the time from the date of randomization to the date of death (including the survival follow-up period) per Kaplan-Meier (KM). |
| Secondary | Trough Plasma Concentrations for Asciminib | Week 2 Day 1 at: 0hr (pre-dose), 0.5hr, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr & 12hr post-dose | Measured concentration at the end of a dosing interval at steady state (taken directly before next administration) |
| Secondary | PK Parameter: Cmax for Asciminib | Week 2 Day 1 at pre-dose, 0.5hr, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr & 12hr post-dose | Maximum (peak) observed plasma concentration after dose administration (mass x volume-1). |
| Secondary | PK Parameter: Tmax for Asciminib | Week 2 Day 1 at: 0hr (pre-dose), 0.5hr, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr & 12hr post-dose | Time to reach maximum (peak) plasma concentration after dose administration (time). Actual sampling times were taken into consideration for the pharmacokinetic analysis. |
| Secondary | PK Parameter: AUC0-12h for Asciminib | Week 2 Day 1 at: 0hr (pre-dose), 0.5hr, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr & 12hr post-dose | Area under the plasma concentration-time curve from time zero to 12 hours (mass x time x volume-1) |
| Secondary | PK Parameter: CL/F for Asciminib | Week 2 day 1 at: 0hr (pre-dose), 0.5hr, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr & 12hr post-dose | Total apparent body clearance of drug from the plasma after oral administration (volume x time-1). |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03106779/registered