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NCT04933526
The Efficacy and Safety of Switching to Flumatinib Versus Dasatinib After Imatinib-related Low-grade Adverse Events in CML-CP Patients
Phase 4 trial testing Flumatinib in Chronic Myeloid Leukemia in Chronic Phase in 118 participants. Status unknown.
30 April 2023
Quick facts
| Lead sponsor | Shenzhen Second People's Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 118 |
| Start date | 1 July 2021 |
| Primary completion | 30 April 2023 |
| Estimated completion | 30 June 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Flumatinib — full drug profile →
- Dasatinib (dasatinib) — full drug profile →
Conditions studied
- Chronic Myeloid Leukemia in Chronic Phase — all drugs for Chronic Myeloid Leukemia in Chronic Phase →
Sponsor
Shenzhen Second People's Hospital
Who can join
18 and older, any sex, with Chronic Myeloid Leukemia in Chronic Phase. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to explore the efficacy and safety of switching to flumatinib versus dasatinib after imatinib-related low-grade adverse events in patients with chronic myeloid leukemia in chronic phase (CML-CP) in China. This is a post-marketing, interventional, double-arm, prospective, open-label, randomized controlled study in CML-CP patients in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given flumatinib or dasatinib under the conditions of informed consent and frequent monitoring according to the clinical guideline.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Resistance to Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia-From Molecular Mechanisms to Clinical Relevance.
Alves R, Gonçalves AC, Rutella S, Almeida AM, et al · · 2021 · cited 112× · PMID 34638304 · DOI 10.3390/cancers13194820 -
Novel targeted therapies in chronic myeloid leukemia.
Ashaq MS, Zhou Q, Li Z, Zhao B. · · 2024 · cited 2× · PMID 41550150 · DOI 10.1016/j.pscia.2024.100052 -
Structure and Dynamics of the ABL1 Tyrosine Kinase and Its Important Role in Chronic Myeloid Leukemia.
Irgit A, Kamıs R, Sever B, Tuyun AF, et al · · 2025 · cited 2× · PMID 40346758 · DOI 10.1002/ardp.70005
Verify or expand the search:
- PubMed search for NCT04933526
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Flumatinib
Trials testing the same drug.
- NCT05433532 — Study of Azacitidine,Venetoclax,and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients · Phase 2 · completed
- NCT05367765 — A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Mye · Phase 4 · not yet recruiting
- NCT05071482 — Flumatinib Versus Imatinib Combined With Chemotherapy for de Novo Ph+ ALL · Phase 4 · terminated
- NCT04677439 — Flumatinib in CML-CP Patients With Ph+ Post Imatinib Failure · Phase 4 · unknown
- NCT04375683 — Study of Efficacy and Safety of Flumatinib Combined With Chemotherapy in Ph Positive ALL · Phase 3 · unknown
Other recruiting trials for Chronic Myeloid Leukemia in Chronic Phase
Currently open trials in the same condition.
- NCT07375355 — Real-world Study of Scemblix in the Treatment of Chronic Myeloid Leukemia in China · recruiting
Other Shenzhen Second People's Hospital trials
Trials by the same sponsor.
- NCT06542016 — An Evaluation of the KCCQ Score in Predicting Cardiovascular Risk in Dialysis Patients · recruiting
- NCT05540808 — The Value of Full-targeted Pathogen Capture Metagenomics Next Generation Sequencing in Etiological Diagnosis of Sepsis · unknown
- NCT05603975 — Analgesic Effect of Esketamine in DCSB in Adultscontrolled Study · NA · unknown
- NCT05465980 — Development and Validation of the Prediction Model for Cognitive Impairment · unknown
- NCT05452759 — Research of Spiral Exhalation Device Oxygen Therapy to Improve the Treatment Effect of Patients With Severe Pneumonia · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04933526 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shenzhen Second People's Hospital
- Last refreshed: 27 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04933526.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing