Clinical trial · Interventional
Bosutinib in Elderly Chronic Myeloid Leukemia
Bosutinib Efficacy, Safety, Tolerability (BEST) Study in Elderly Chronic Myeloid Leukemia Patients Failing Front-line Treatment With Other Tyrosine Kinase Inhibitors
NCT02810990CI-TRIAL-00063653BESTcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of the present study is to evaluate a new drug called bosutinib as it is believed that this agent may be able to predict an excellent prognosis in patients that did not obtain any benefit with other drugs before. Still, this needs to be proved and we hope this study is able to do so.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bosutinib | Drug | Bosutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bosutinib treatment
- interventionNames
- Drug: Bosutinib
Primary outcomes (1)
- measure
- Number of patients who are in major molecular response (MMR)
- timeFrame
- One year treatment
Secondary outcomes (7)
- measure
- Number of patients who obtain molecular response
- timeFrame
- At 6 and 12 months from treatment start
- measure
- Number of patients discontinuing treatment for failure, adverse events or other reasons
- timeFrame
- At 12 and 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Molecular confirmed diagnosis of BCR-ABL1+ CML 2. Chronic phase CML (ELN 2013 criteria) 3. 60 years of age or older 4. Prior first-line treatment with any other TKIs 5. Intolerance to prior treatment, based on investigator and patient assessment or failure of prior treatment according to any one of the ELN 2013 criteria, as listed below * Non complete hematologic response (CHR) at 3 months * No cytogenetic response (Ph+ \> 95%) at 6 months * Less than Partial Cytogenetic Response (PCyR) (Ph+ \>35%) at 6 months * BCR-ABL1 \> 10% at 6 months * Non complete CyR (CCyR) (Ph+ \> 0) at 12 months * BCR-ABL1 \> 1% at 12 months * Loss of CHR at any time * Loss of CCyR at any time * Confirmed loss of major molecular response (MMR) (BCR-ABL1 \> 0.1%) in two consecutive tests, of which one \> 1%, at any time 6. An effective form of contraception from enrolment through 30 days after the end of treatment 7. Signed written informed consent according to ICH/EU/GCP and national and local laws prior to any study procedures 8. Willingness and ability to comply with scheduled visits and study procedures. Exclusion Criteria: 1. Accelerated or blastic phase CML (according to ELN 2013 criteria) 2. Patients with the T315I or the V299L mutation 3. Patients previously treated with 2 TKIs or more 4. Compelled to take medications that are known to be associated with Torsades de Pointes and/or with significant QTc prolongation 5. Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the drug 6. HBV markers positivity 7. Lack of informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.