Trial · NCT04971226
A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
NCT04971226, Phase 3, Active not recruiting, Novartis Pharmaceuticals; results first posted 2025-03-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP. Trials, record NCT04971226. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04971226
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
- NCT number
- NCT04971226
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 405 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive
- Interventions
- Imatinib, Nilotinib, Bosutinib, Dasatinib, Asciminib
- First posted
- 2021-07-21
- Last updated
- 2026-08-28
- Results first posted
- 2025-03-10
- Limitations and caveats
- Adverse Events data were not collected from the 4 participants who are not included in the Safety Set as they did not receive any treatment.
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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). |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI | At 48 weeks | The Full Analysis Set (FAS) comprised of all participants to whom study treatment has been assigned by randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Major Molecular Response at Week 96 | at 96 weeks (96 weeks after last patient first dose) | |||
| SECONDARY | Time to Discontinuation of Study Treatment Due to Adverse Events (TTDAE) | 96 weeks after last patient first dose | |||
| SECONDARY | Major Molecular Response at Scheduled Data Collection Time Points | Planned total follow-up duration of 5 years | |||
| SECONDARY | Major Molecular Response by Scheduled Data Collection Time Points | Planned total follow-up duration of 5 years | |||
| SECONDARY | MR4.0 at Scheduled Data Collection Time Points | Planned total follow-up duration of 5 years | |||
| SECONDARY | MR4.5 at All Scheduled Data Collection Time Points | Planned total follow-up duration of 5 years | |||
| SECONDARY | MR4.0 by Scheduled Data Collection Time Points | Planned total follow-up duration of 5 years | |||
| SECONDARY | MR4.5 by All Scheduled Data Collection Time Points | Planned total follow-up duration of 5 years | |||
| SECONDARY | Complete Hematological Response (CHR) at All Scheduled Data Collection Time Points | Planned total follow-up duration of 5 years |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group314
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI | Asciminib (All Asciminib ) | 136 | Participants | ||
| Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI | Investigator Selected TKI (All Comparators) | 100 | Participants | ||
| Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96 | Asciminib (All Asciminib ) | Complete cytogenetic response (CCyR) | 1 | Participants | |
| Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96 | Investigator Selected TKI (All Comparators) | Complete cytogenetic response (CCyR) | 0 | Participants | |
| Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96 | Asciminib (All Asciminib ) | Partial cytogenetic response (PCyR) | 1 | Participants | |
| Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96 | Investigator Selected TKI (All Comparators) | Partial cytogenetic response (PCyR) | 0 | Participants | |
| Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96 | Asciminib (All Asciminib ) | Minor cytogenetic response (mCyR) | 0 | Participants | |
| Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96 | Investigator Selected TKI (All Comparators) | Minor cytogenetic response (mCyR) | 0 | Participants | |
| Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96 | Asciminib (All Asciminib ) | Minimal cytogenetic response | 0 | Participants | |
| Percentage of Participants With Complete Cytogenic Response (CCyR) by Week 48 & Week 96 | Investigator Selected TKI (All Comparators) | Minimal cytogenetic response | 0 | Participants |
1 to 10 of 314Source ClinicalTrials.gov
See all 314 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Asciminib (Imatinib Stratum) | 101 | |
| Overall Study | STARTED | Asciminib (2nd Generation TKI Stratum) | 100 | |
| Overall Study | STARTED | Investigator Selected TKI (Imatinib Stratum) | 102 | |
| Overall Study | STARTED | Investigator Selected TKI (2nd Generation TKI Stratum | 102 | |
| Overall Study | Participants Not Treated | Asciminib (Imatinib Stratum) | 1 | |
| Overall Study | Participants Not Treated | Asciminib (2nd Generation TKI Stratum) | 0 | |
| Overall Study | Participants Not Treated | Investigator Selected TKI (Imatinib Stratum) | 2 | |
| Overall Study | Participants Not Treated | Investigator Selected TKI (2nd Generation TKI Stratum | 1 | |
| Overall Study | Treated | Asciminib (Imatinib Stratum) | 100 | |
| Overall Study | Treated | Asciminib (2nd Generation TKI Stratum) | 100 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events452
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Asciminib (All Asciminib) | 23 | 200 | |
| other | Anaemia | Blood and lymphatic system disorders | Imatinib | 26 | 99 | |
| other | Anaemia | Blood and lymphatic system disorders | 2nd Generation TKI | 23 | 102 | |
| other | Anaemia | Blood and lymphatic system disorders | All Comparators | 49 | 201 | |
| other | Leukopenia | Blood and lymphatic system disorders | Asciminib (All Asciminib) | 16 | 200 | |
| other | Leukopenia | Blood and lymphatic system disorders | Imatinib | 12 | 99 | |
| other | Leukopenia | Blood and lymphatic system disorders | 2nd Generation TKI | 7 | 102 | |
| other | Leukopenia | Blood and lymphatic system disorders | All Comparators | 19 | 201 | |
| other | Neutropenia | Blood and lymphatic system disorders | Asciminib (All Asciminib) | 21 | 200 | |
| other | Neutropenia | Blood and lymphatic system disorders | Imatinib | 15 | 99 |
1 to 10 of 452Source ClinicalTrials.gov
See all 452 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Asciminib (All Asciminib) | 0 | 200 |
| Total, all-cause mortality | Imatinib | 0 | 99 |
| Total, all-cause mortality | 2nd Generation TKI | 0 | 102 |
| Total, all-cause mortality | All Comparators | 0 | 201 |
| Total, other adverse events | Asciminib (All Asciminib) | 177 | 200 |
| Total, other adverse events | Imatinib | 89 | 99 |
| Total, other adverse events | 2nd Generation TKI | 100 | 102 |
| Total, other adverse events | All Comparators | 189 | 201 |
| Total, serious adverse events | Asciminib (All Asciminib) | 22 | 200 |
| Total, serious adverse events | Imatinib | 12 | 99 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Asciminib (All Asciminib ) vs Investigator Selected TKI (All Comparators): Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI | Trial comparisons |
Asciminib (Imatinib Stratum) vs Investigator Selected TKI (Imatinib Stratum): Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Asciminib (Imatinib Stratum) vs Investigator Selected TKI (Imatinib Stratum) | Trial comparisons |
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/NCT04971226
GET https://conductscience.org/api/trials/v1/NCT04971226/registered?page=2