Trial · NCT04971226
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI | At 48 weeks | Molecular response is assessed using BCR-ABL1 transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value). |
| Primary | Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Asciminib (Imatinib Stratum) vs Investigator Selected TKI (Imatinib Stratum) | At 48 weeks | Molecular response is assessed using BCR-ABL1 transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL1/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value). |
| Secondary | Major Molecular Response at Week 96 | at 96 weeks (96 weeks after last patient first dose) | Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value). |
| Secondary | Time to Discontinuation of Study Treatment Due to Adverse Events (TTDAE) | 96 weeks after last patient first dose | TTDAE is defined as the time from the date of first dose of study treatment to the date of discontinuation of study treatment due to Adverse Event (AE). For patients ongoing without study treatment discontinuation, on or prior to the analysis cut-off date, the time will be censored at the at the analysis cut-off date. |
| Secondary | Major Molecular Response at Scheduled Data Collection Time Points | Planned total follow-up duration of 5 years | Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value). |
| Secondary | Major Molecular Response by Scheduled Data Collection Time Points | Planned total follow-up duration of 5 years | Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value). |
| Secondary | MR4.0 at Scheduled Data Collection Time Points | Planned total follow-up duration of 5 years | Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.0 is defined as a ratio BCR-ABL/ABL ≤0.01% on the international scale (ie, at least 4 log reduction from a standardized baseline value). |
| Secondary | MR4.5 at All Scheduled Data Collection Time Points | Planned total follow-up duration of 5 years | Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.5 is defined as a ratio BCR-ABL/ABL ≤0.0032% on the international scale (ie, at least 4.5 log reduction from a standardized baseline value). |
| Secondary | MR4.0 by Scheduled Data Collection Time Points | Planned total follow-up duration of 5 years | Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.0 is defined as a ratio BCR-ABL/ABL ≤0.01% on the international scale (ie, at least 4 log reduction from a standardized baseline value). |
| Secondary | MR4.5 by All Scheduled Data Collection Time Points | Planned total follow-up duration of 5 years | Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.5 is defined as a ratio BCR-ABL/ABL ≤0.0032% on the international scale (ie, at least 4.5 log reduction from a standardized baseline value). |
| Secondary | Complete Hematological Response (CHR) at All Scheduled Data Collection Time Points | Planned total follow-up duration of 5 years | Hematologic response will be assessed by CBC and physical examination at each visit. Complete Hematological Response (CHR) will be defined as all of the following present for ≥ 4 weeks: white blood cell(s) (WBC) count \< 10 x 10\^9/L PLT count \< 450 x 10\^9/L Basophils \< 5% No blasts and promyelocytes in peripheral blood Myelocytes + metamyelocytes \< 5% in peripheral blood No evidence of extramedullary disease, including spleen and liver |
| Secondary | Complete Hematological Response (CHR) by All Scheduled Data Collection Time Points | Planned total follow-up duration of 5 years | Hematologic response will be assessed by CBC and physical examination at each visit. Complete Hematological Response (CHR) will be defined as all of the following present for ≥ 4 weeks: white blood cell(s) (WBC) count \< 10 x 10\^9/L PLT count \< 450 x 10\^9/L Basophils \< 5% No blasts and promyelocytes in peripheral blood Myelocytes + metamyelocytes \< 5% in peripheral blood No evidence of extramedullary disease, including spleen and liver |
| Secondary | Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96 | By week 48 and by week 96 (48 weeks and 96 weeks after last patient first dose); data collection/analysis is ongoing for the 96 week time point, and the data will be reported later | The CCyR response status was to be based on bone marrow assessment. Bone marrow examination for cytogenetic assessment was to be performed locally by the Investigator at baseline for all participants. Thereafter, during the course of the study, cytogenetic assessment was not mandatory and only performed if clinically indicated. |
| Secondary | Duration of MMR | Planned total follow-up duration of 5 years | Duration of MMR is defined as the time between the date of the first documented achievement of MMR and the earliest date of loss of MMR, treatment failure, progression to Accelerated Phase/Blast Crisis, or CML-related death |
| Secondary | Duration of MR4.0 | Planned total follow-up duration of 5 years | Duration of MR4.0 is defined as the time between the date of the first documented achievement of MR4.0 and the earliest date of loss of MR4.0, treatment failure, progression to Accelerated Phase/Blast Crisis, or CML-related death |
| Secondary | Duration of MR4.5 | Planned total follow-up duration of 5 years | Duration of MR4.5 is defined as the time between the date of the first documented achievement of MR4.5 and the earliest date of loss of MR4.5, treatment failure, progression to Accelerated Phase/Blast Crisis, or CML-related death |
| Secondary | Time to First MMR | Planned total follow-up duration of 5 years | Time to first MMR is defined as the time from the date of randomization to the date of the first documented occurrence of MMR. Time will be censored at the last molecular assessment date while on treatment, or the End Of Treatment (whichever comes first) for patients who have not experienced MMR. |
| Secondary | Time to First MR4.0 | Planned total follow-up duration of 5 years | Time to first MR4.0 is defined as the time from the date of randomization to the date of the first documented occurrence of MR4.0. Time will be censored at the last molecular assessment date while on treatment, or the End Of Treatment (whichever comes first) for patients who have not experienced MR4.0. |
| Secondary | Time to First MR4.5 | Planned total follow-up duration of 5 years | Time to first MR4.5 is defined as the time from the date of randomization to the date of the first documented occurrence of MR4.5. Time will be censored at the last molecular assessment date while on treatment, or the End Of Treatment (whichever comes first) for patients who have not experienced MR4.5. |
| Secondary | BCR-ABL1≤1% at Scheduled Data Collection Time Points | Planned total follow-up duration of 5 years | Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. |
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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