18 and older, any sex, with Blasts Under 15 Percent of Bone Marrow Nucleated Cells or Blasts Under 15 Percent of Peripheral Blood White Cells. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Response RatePrimary· 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.
Group
Value
95% CI
Treatment (Bosutinib)
6
Number of Participants With Treatment Interruptions and Dose ReductionsSecondary· Up to 2 years
Will be summarized.
Interruptions
Group
Value
95% CI
Treatment (Bosutinib)
6
Reductions
Group
Value
95% CI
Treatment (Bosutinib)
4
Rates of Major Molecular Response (MR), MR4, MR4.5 and Complete Molecular ResponseSecondary· 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%).
Complete Molecular Response (CMR)
Group
Value
95% CI
Treatment (Bosutinib)
2
MR4.5
Group
Value
95% CI
Treatment (Bosutinib)
3
MR4
Group
Value
95% CI
Treatment (Bosutinib)
3
Major Molecular Response (MMR)
Group
Value
95% CI
Treatment (Bosutinib)
5
Rates of BCR-ABL/ABL <10%Secondary· At 3 months
Will be assessed using the international scale. Will be estimated along with the exact 95% confidence intervals.
Group
Value
95% CI
Treatment (Bosutinib)
3
Rates of BCR-ABL/ABL < 1%Secondary· At 6 months
Will be assessed using the international scale. Will be estimated along with the exact 95% confidence intervals.
Group
Value
95% CI
Treatment (Bosutinib)
2
Overall SurvivalSecondary· 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.
Group
Value
95% CI
Treatment (Bosutinib)
20.26
13.63 – 22.90
Event-free SurvivalSecondary· Up to 2 years
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Group
Value
95% CI
Treatment (Bosutinib)
13.97
3.06 – 22.90
Transformation-free SurvivalSecondary· 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.
Group
Value
95% CI
Treatment (Bosutinib)
13.97
3.75 – 22.90
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 2 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies how well bosutinib works in treating patients with chronic myeloid leukemia in chronic phase after frontline tyrosine kinase inhibitor (TKI) failure. Bosutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04877522 — Asciminib Roll-over Study
· Phase 4
· recruiting
NCT05032690 — Evaluation of the Relative Bioavailability of Bosutinib Capsules Under Fed Condition and Estimation of Food Effect on Or
· Phase 1
· completed
NCT05363488 — Retrospective Observational Research Study to Describe the Real World Use of Bosutinib in a Single Centre in Scotland
· completed
NCT04971226 — A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
· Phase 3
· active not recruiting
NCT05286528 — Study to Evaluate Chronic Myeloid Leukemia Treatment Landscape and Real-life Treatment Outcomes in Hungary: Analysis of
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 11 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02906696.