Trial · NCT03106779
Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs
NCT03106779, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2022-02-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs. Trials, record NCT03106779. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03106779
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs
- NCT number
- NCT03106779
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 233 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Myelogenous Leukemia
- Interventions
- Asciminib, Bosutinib
- First posted
- 2017-04-10
- Last updated
- 2026-08-18
- Other registries' IDs
- eudract:2016-002461-66
- Results first posted
- 2022-02-15
- Limitations and caveats
- In the asciminib arm, 2 patients died on-treatment and 2 patients died during survival follow-up. In the bosutinib arm, 1 patient died on-treatment.
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Major Molecular Response (MMR) Rate at 24 Weeks | 24 weeks | Full Analysis Set (FAS): The FAS comprised of all randomized patients. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Major Molecular Response (MMR) Rate | 96 weeks after the last patient received the first study dose | |||
| SECONDARY | Complete Cytogenetic Response Rate | 96 weeks after the last patient received the first study dose | |||
| SECONDARY | Time to MMR | 96 weeks after the last patient received the first study dose | |||
| SECONDARY | Duration of MMR | 96 weeks after the last patient received the first study dose | |||
| SECONDARY | Time to CCyR | 96 weeks after the last patient received the first study dose | |||
| SECONDARY | Duration of CCyR | 96 weeks after the last patient received the first study dose | |||
| SECONDARY | Time to Treatment Failure | 96 weeks after the last patient received the first study dose | |||
| SECONDARY | Progression Free Survival | 96 weeks after the last patient received the first study dose | |||
| SECONDARY | Overall Survival | 96 weeks after the last patient received the first study dose |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Major Molecular Response (MMR) Rate at 24 Weeks | Asciminib | 40 | Participants | ||
| Number of Participants With Major Molecular Response (MMR) Rate at 24 Weeks | Bosutinib | 10 | Participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Asciminib | 157 | |
| Overall Study | STARTED | Bosutinib | 76 | |
| Overall Study | Treated | Asciminib | 156 | |
| Overall Study | Treated | Bosutinib | 0 | |
| Overall Study | Not Treated | Asciminib | 1 | |
| Overall Study | Not Treated | Bosutinib | 0 | |
| Overall Study | COMPLETED | Asciminib | 97 | |
| Overall Study | COMPLETED | Bosutinib | 22 | |
| Overall Study | NOT COMPLETED | Asciminib | 60 | |
| Overall Study | NOT COMPLETED | Bosutinib | 54 |
Source ClinicalTrials.gov
Adverse events170
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 | 15 | 156 | |
| other | Anaemia | Blood and lymphatic system disorders | Bosutinib | 6 | 76 | |
| other | Neutropenia | Blood and lymphatic system disorders | Asciminib | 28 | 156 | |
| other | Neutropenia | Blood and lymphatic system disorders | Bosutinib | 13 | 76 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Asciminib | 35 | 156 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bosutinib | 10 | 76 | |
| other | Abdominal pain | Gastrointestinal disorders | Asciminib | 7 | 156 | |
| other | Abdominal pain | Gastrointestinal disorders | Bosutinib | 11 | 76 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Asciminib | 7 | 156 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Bosutinib | 5 | 76 |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Asciminib | 4 | 156 |
| Total, all-cause mortality | Bosutinib | 1 | 76 |
| Total, other adverse events | Asciminib | 122 | 156 |
| Total, other adverse events | Bosutinib | 69 | 76 |
| Total, serious adverse events | Asciminib | 21 | 156 |
| Total, serious adverse events | Bosutinib | 14 | 76 |
Source ClinicalTrials.gov
Papers5
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Asciminib vs Bosutinib: Number of Participants With Major Molecular Response (MMR) Rate at 24 Weeks | Trial comparisons |
| Asciminib vs Bosutinib: deaths from any cause | Trial comparisons |
| Asciminib vs Bosutinib: serious adverse events | 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/NCT03106779
GET https://conductscience.org/api/trials/v1/NCT03106779/events?page=2