Clinical trial · Interventional
A Phase II Study to Evaluate the Efficacy and the Safety of Flumatinib in CML-AP or CML-BP Patients
Multi-center, Single Stage Phase II Study to Evaluate the Efficacy and Safety of Flumatinib in Accelerated or Blastic Phase Chronic Myelogenous Leukemia Patients
NCT02511340CI-TRIAL-00018712unknownPhase 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)
Multi-center, single stage, phase II study to evaluate the efficacy and safety of Flumatinib in accelerated or blastic Phase chronic myelogenous leukemia patients.
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 Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flumatinib mesylate tablet 600 mg qd | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Flumatinib mesylate tablet 600 mg qd
- description
- Flumatinib, 600mg, qd
- interventionNames
- Drug: Flumatinib mesylate tablet 600 mg qd
Primary outcomes (1)
- measure
- Confirmed overall hematologic response(OHR)at 6 months
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients age 18-75 year-old; * ECOG 0 - 2; * Newly diagnosed or previously treated Ph+ CML patients in accelerated or blastic Phase; * Adequate organ function; * Written informed consent prior to any study procedures being performed. Exclusion Criteria: * Patients in Chronic and Blastic Phases; * Previously treated with Flumatinib; * Previously documented T315I mutations; * Previous therapy within protocol defined timeframe, including: * hydroxyurea within 24 hr, * Imatinib or Nilotinib or Dasatinib within 28 days) * Cardiac dysfunction ; * History of congenital or acquired bleeding disorders unrelated to CML; * Central nervous system leukemia; * Previous malignancy except CML; * Acute or chronic liver or severe kidney disease unrelated to CML; * Pregnant, breastfeeding, child bearing potential but failed to take effective contraception.
References
Publications (0)
Data not yet available
No reference posted for this study.