Clinical trial · Interventional
The Study of the Efficacy and the Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With CML
Randomized, Multi-center, Open-label Phase III Study of the Efficacy and Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia.
NCT02204644CI-TRIAL-00031827completedPhase 3ClinicalTrials.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)
A study to observe the efficacy and the safety of Flumatinib vs Imatinib as first line treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia. Randomized,Open Label,Control
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, CML-CP,MMR,TKI | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flumatinib 600mg qd | Drug | — | UNRESOLVED |
| Imatinib 400mg qd | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Flumatinib mesylate tablets
- description
- Flumatinib mesylate tablets 600mg qd for 12 months
- interventionNames
- Drug: Flumatinib 600mg qd
- type
- ACTIVE_COMPARATOR
- label
- Imatinib mesylate tablets
- description
- Imatinib mesylate tablets 400mg qd for 12months
- interventionNames
- Drug: Imatinib 400mg qd
Primary outcomes (1)
- measure
- SIX-month major molecular response rate
- timeFrame
- six months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men and women aged 18-75 year-old 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 3. Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph + CP-CML) within 6 months of diagnosis 4. Adequate organ function Exclusion Criteria: 1. received TKIs drug treatment before enrollment 2. Central nervous system leukemia 3. Previous anti-CML therapy over two weeks (hydroxyurea, except anagrelide) or surgery (including hematopoietic stem cell transplantation) 4. Cardiac dysfunction 5. Previous splenectomy 6. History of congenital or acquired bleeding disorders unrelated to CML 7. Previous malignancy except CML 8. Acute or chronic liver or severe kidney disease unrelated to CML 9. Pregnant, breastfeeding, child bearing potential but failed to take effective contraception
References
Publications (1)
- DERIVEDZhang L, Meng L, Liu B, Zhang Y, Zhu H, Cui J, Sun A, Hu Y, Jin J, Jiang H, Zhang X, Li Y, Liu L, Zhang W, Liu X, Gu J, Qiao J, Ouyang G, Liu X, Luo J, Jiang M, Xie X, Li J, Zhao C, Zhang M, Yang T, Wang J. Flumatinib versus Imatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: A Phase III, Randomized, Open-label, Multi-center FESTnd Study. Clin Cancer Res. 2021 Jan 1;27(1):70-77. doi: 10.1158/1078-0432.CCR-20-1600. Epub 2020 Sep 14. PMID 32928796