Clinical trial · Observational
TKI Discontinuation in CML Patients of China
Tyrosine Kinase Inhibitor Discontinuation in Adults Patients With Chronic Myeloid Leukemia in China
- 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 primary objective of this study is to describe the maintenance of the molecular remission after tyrosine kinase inhibitor (TKI) disconnection in chronic myeloid leukaemia (CML) patients in China in the real-world clinical practice setting. This is a post-marketing, non-interventional, single-arm, prospective registry study in adult patients with chronic phase (CP) and accelerated phase (AP) in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be undertaking TKI discontinuation under the conditions of informed consent and frequent monitoring according to the clinical guideline.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BCR-ABL (Breakpoint Cluster Region-abelson Murine Leukemia) | — | UNRESOLVED | — |
| Chronic | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelogenous | — | UNRESOLVED | — |
| Positive | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- TKI Discontinuation Group
- description
- The enrolled patients will be undertaking TKI discontinuation under the conditions of informed consent and frequent monitoring according to the clinical guideline.
Primary outcomes (1)
- measure
- Molecular Remission Rate
- timeFrame
- at 12 months
- description
- The molecular remission rate
Secondary outcomes (3)
- measure
- Adverse Events
- timeFrame
- through study completion, an average of 1 year
- description
- Incidence of Treatment-free related Adverse Events
- measure
- Recurrence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults with CML-CP/AP and willingness of TKI discontinuation; * With ≥ 5 years frontline imatinib, reached MMR (major molecular response) in 2 years, with ≥ 2 years MR (molecular response) 4.5; * Reached MMR with frontline imatinib, with ≥ 2 years nilotinib, with ≥ 1 year MR4.5; * Failure with frontline imatinib, reached MMR in 1 year with nilotinib, with ≥ 2 years MR4.5; * With ≥ 3 years frontline imatinib, reached MMR in 1 year, with ≥ 2 years MR4.5. Exclusion Criteria: * Diagnosed with CML-BP before TKI treatment; * With a TKI discontinuation of over 30 days in the first year; * With a TKI discontinuation of over 30days on average annually; * Reduced the dosage of TKI treatment without instructions; * Transferred to the second-generation TKIs after resistance to imatinib. * Under the treatment of stem cells transplantation
References
Publications (0)
Data not yet available