Clinical trial · Interventional
A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Evaluating the Efficacy and Safety of Flumatinib Versus Imatinib for in Patients With Newly Diagnosed Chronic Myeloid Leukemia (CML)-in Chronic Phase (CP): A Multicenter, Open-label, Real World Study
- 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)
Flumatinib is an orally available TKI with high selectivity and potency against BCR-ABL1 kinase. It's a multi-center, open-label, real world study to explore the efficacy and safety of Flumatinib versus Imatinib as the first line therapy in patients with chronic myleiod leukemia(CML) in chronic phase(CP).
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 |
|---|---|---|---|
| CML, Chronic Phase | Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flumatinib | Drug | — | UNRESOLVED |
| Imatinib | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Flumatinib mesylate tablets
- interventionNames
- Drug: Flumatinib
- type
- ACTIVE_COMPARATOR
- label
- Imatinib mesylate tablets
- interventionNames
- Drug: Imatinib
Primary outcomes (1)
- measure
- Major molecular response (MMR) rate at 12 months
- timeFrame
- 12 months
- description
- MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale as measured by RQ-PCR
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men or women aged more than or equal to (≥) 18 years. 2. Patients with Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase (Ph+ CML-CP) within 6 months of diagnosis.. 3. Eastern Cooperative Oncology Group (ECOG) performance status: 0\~2. 4. Signed and dated Informed Consent Form. Exclusion Criteria: 1. Patients with previously documented T315I mutation. 2. Received BCR-ABL TKI(s) treatment before enrollment. 3. Any treatment with anti-CML therapy over 2 weeks or hematopoietic stem cell transplantation before enrollment 4. Participated in other clinical trials that might affect the efficacy and safety of CML during this study. 5. Pregnant or lactating female.
References
Publications (0)
Data not yet available