Clinical trial · Interventional
Flumatinib in CML-CP Patients With Ph+ Post Imatinib Failure
Efficacy and the Safety of Flumatinib in Treatment of CML-CP Patients With Ph+ Post Imatinib Failure
NCT04677439CI-TRIAL-00057139unknownPhase 4ClinicalTrials.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 purpose of this study is to explore the efficacy and safety of flumatinib in chronic phase of chronic myeloid leukemia (CML-CP) patients With Ph+ post imatinib failure.
Conditions
Conditions (3)
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 Phase | Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Flumatinib | — | UNRESOLVED | — |
| Imatinib | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flumatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Flumatinib
- interventionNames
- Drug: Flumatinib
Primary outcomes (1)
- measure
- Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test.
- timeFrame
- 12 months
- description
- Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent.
Secondary outcomes (4)
- measure
- Proportion of patients with MR 4.0 at 3, 6, 9, 12 months.
- timeFrame
- 3, 6, 9, 12 months.
- description
- Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01 percent.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * Diagnosis of CML-CP with Ph+. * ECOG performance of 0-2. * Adequate end organ function defined as the following: total bilirubin \<1.5x ULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN. * Treatment failure after imatinib at 3 or 6 months with BCR-ABL \>10%. * Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital. Exclusion Criteria: * Previously documented T315I mutation. * History of TKI treatments except of imatinib. * History of undergone major surgery within 4 weeks. * Patients unwilling or unable to comply with the protocol. * Pregnant or breast-feeding patients. * patients with other malignant tumor.
References
Publications (0)
Data not yet available
No reference posted for this study.