Trial · NCT02906696
Bosutinib in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase After Frontline TKI Failure
NCT02906696, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2020-04-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bosutinib in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase After Frontline TKI Failure. Trials, record NCT02906696. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02906696
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bosutinib in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase After Frontline TKI Failure
- NCT number
- NCT02906696
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
Blasts Under 15 Percent of Bone Marrow Nucleated Cells, Blasts Under 15 Percent of Peripheral Blood White Cells, Blasts Under 30 Percent of Bone Marrow Nucleated Cells, Blasts Under 30 Percent of Peripheral Blood White Cells, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Interventions
- Bosutinib, Laboratory Biomarker Analysis
- First posted
- 2016-09-20
- Last updated
- 2020-05-11
- Results first posted
- 2020-04-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate | Up to 6 months | Response is defined as follows: 1) For patients who do not currently have a partial cytogenetic response (PCyR), achievement of major cytogenetic response is considered a response. 2) For patients who are currently in PCyR, achievement of CCyR is considered a response. The Simon's optimal two-stage design will be used for interim futility monitoring. Will be estimated along with the 95% credible interval. |
| Secondary | Number of Participants With Treatment Interruptions and Dose Reductions | Up to 2 years | Will be summarized. |
| Secondary | Rates of Major Molecular Response (MR), MR4, MR4.5 and Complete Molecular Response | Up to 2 years | Will be estimated along with the exact 95% confidence intervals. Molecular assessments are based on quantitative reverse transcriptase polymerase chain reaction for Bcr-Abl in peripheral blood. Molecular response is categorized as MMR (Bcr-Abl/Abl ratio of \</= 0.1% in the international scale), MR4 (Bcr-Abl/Abl \</= 0.01%), and MR4.5 (BCR-ABL/ABL \</=0.0032%). |
| Secondary | Rates of BCR-ABL/ABL <10% | At 3 months | Will be assessed using the international scale. Will be estimated along with the exact 95% confidence intervals. |
| Secondary | Rates of BCR-ABL/ABL < 1% | At 6 months | Will be assessed using the international scale. Will be estimated along with the exact 95% confidence intervals. |
| Secondary | Overall Survival | Up to 2 years | Will be assessed by Kaplan-Meier methods. Cox proportional hazards regression models will be fit to assess the association between patient characteristics including survival outcome. Time from date of treatment start until date of death due to any cause or last Follow-up. |
| Secondary | Event-free Survival | Up to 2 years | Time from date of treatment start until the date of first objective documentation of disease-relapse. |
| Secondary | Transformation-free Survival | Up to 2 years | Will be assessed by Kaplan-Meier methods. Transformation-free survival is defined as the time from treatment initiation until either progression to AP/BP or death from any cause. |
| Secondary | Change of ABL Kinase Domain Mutation Status | Baseline up to 2 years | Will be summarized and its association with survival outcomes will be analyzed through landmark analyses. Cox proportional hazards regression models will be fit to assess the association between patient characteristics including ABL kinase domain mutation status. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate | Up to 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Treatment Interruptions and Dose Reductions | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rates of Major Molecular Response (MR), MR4, MR4.5 and Complete Molecular Response | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rates of BCR-ABL/ABL <10% | At 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rates of BCR-ABL/ABL < 1% | At 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | Up to 2 years | Months | MEDIAN | |
| SECONDARY | Event-free Survival | Up to 2 years | Months | MEDIAN | |
| SECONDARY | Transformation-free Survival | Up to 2 years | Months | MEDIAN | |
| SECONDARY | Change of ABL Kinase Domain Mutation Status | Baseline up to 2 years | There were not any at the start of treatment so there were not any mutation status to follow. These were not done. |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate | Treatment (Bosutinib) | 6 | Participants | ||
| Number of Participants With Treatment Interruptions and Dose Reductions | Treatment (Bosutinib) | Interruptions | 6 | Participants | |
| Number of Participants With Treatment Interruptions and Dose Reductions | Treatment (Bosutinib) | Reductions | 4 | Participants | |
| Rates of Major Molecular Response (MR), MR4, MR4.5 and Complete Molecular Response | Treatment (Bosutinib) | Complete Molecular Response (CMR) | 2 | Participants | |
| Rates of Major Molecular Response (MR), MR4, MR4.5 and Complete Molecular Response | Treatment (Bosutinib) | MR4.5 | 3 | Participants | |
| Rates of Major Molecular Response (MR), MR4, MR4.5 and Complete Molecular Response | Treatment (Bosutinib) | MR4 | 3 | Participants | |
| Rates of Major Molecular Response (MR), MR4, MR4.5 and Complete Molecular Response | Treatment (Bosutinib) | Major Molecular Response (MMR) | 5 | Participants | |
| Rates of BCR-ABL/ABL <10% | Treatment (Bosutinib) | 3 | Participants | ||
| Rates of BCR-ABL/ABL < 1% | Treatment (Bosutinib) | 2 | Participants | ||
| Overall Survival | Treatment (Bosutinib) | 20.26 | Full Range 13.63 to 22.90 | Months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Bosutinib) | 8 | |
| Overall Study | COMPLETED | Treatment (Bosutinib) | 8 | |
| Overall Study | NOT COMPLETED | Treatment (Bosutinib) | 0 |
Source ClinicalTrials.gov
Adverse events30
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 | Abdominal Pain | General disorders | Treatment (Bosutinib) | 2 | 8 | 2 |
| other | Elevated Alanine transaminase | Investigations | Treatment (Bosutinib) | 4 | 8 | 11 |
| other | Angioedema | Blood and lymphatic system disorders | Treatment (Bosutinib) | 1 | 8 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Treatment (Bosutinib) | 2 | 8 | 2 |
| other | Aspartate transaminase | Investigations | Treatment (Bosutinib) | 2 | 8 | 4 |
| other | Bruising | Injury, poisoning and procedural complications | Treatment (Bosutinib) | 1 | 8 | 1 |
| other | Chest Pain | General disorders | Treatment (Bosutinib) | 1 | 8 | 1 |
| other | Elevated Creatinine | Investigations | Treatment (Bosutinib) | 1 | 8 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Bosutinib) | 7 | 8 | 7 |
| other | Fatigue | General disorders | Treatment (Bosutinib) | 5 | 8 | 5 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Bosutinib) | 0 | 8 |
| Total, other adverse events | Treatment (Bosutinib) | 8 | 8 |
| Total, serious adverse events | Treatment (Bosutinib) | 4 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02906696
GET https://conductscience.org/api/trials/v1/NCT02906696/events?page=2