Clinical trial · Interventional
HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukemia: a Multicenter, Open-label, Randomized Phase 3 Trial
NCT05586074CI-TRIAL-00109589recruitingPhase 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 randomized，multicenter, open-label Phase III, clinical study is conducted to evaluate the clinical benefit Clifutinib in Chinese patients with relapsed/ refractory (R/R) FLT3-mutated AML as shown with overall survival compared to salvage chemotherapy, and also to investigate the efficacy of Clifutinib as assessed by CR/CRh rate in these subjects.
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 |
|---|---|---|---|
| Leukemia, Acute Myeloid (AML) | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ara-C±IDA | Drug | — | UNRESOLVED |
| Azacitidine | Drug | Azacitidine | ALIAS |
| Clifutinib | Drug | — | UNRESOLVED |
| Decitabine | Drug | Decitabine | ALIAS |
| FLAG-IDA | Drug | — | UNRESOLVED |
| LoDAC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Clifutinib
- description
- Subjects received 40 mg dose orally once a day in continuous 28-day cycles, at least 2 hours before and after food. Clifutinib treatment continued until sujects met one of the treatment discontinuation criteria.
- interventionNames
- Drug: Clifutinib
- type
- ACTIVE_COMPARATOR
- label
- Salvage Chemotherapy
- description
- Subjects received chemotherapy in 28-day cycles. Subjects on Low-Dose Cytarabine (LoDAC) received 10 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10\~14 days. Subjects on azacitidine received 75 mg/m\^2 daily by SC for 7 days. Subjects on decitabine received 20 mg/m\^2 daily by IV injection for 5 days. Subjects on LoDAC or azacitidine or decitabine treatment continued until they met discontinuation criteria. Subjects on Ara-C±IDA chemotherapy received cytarabine 1\~3 g/m\^2 daily by IV for 3 days and idarubicin 10 mg/m\^2 daily by IV for 3 days. Participants on FLAG-IDA chemotherapy received G-CSF 300 μg/m\^2 daily by SC for 6 days (days 1-6), fludarabine 30 mg/m\^2 daily by IV for 5 days (days 2-6), cytarabine 1\~2 g/m\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\^2 daily by IV for 3 days (days 2-4). Subjects receiving Ara-C±IDA or FLAG-IDA received 1 cycle of therapy and were assessed for response on day 28+/-2 days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject is ≥ 18 years of age at the time of obtaining informed consent. * Subject has a diagnosis of primary acute myeloid leukemia (AML) or AML secondary to myelodysplastic syndrome (MDS) according to WHO classification; * Subject is refractory to or relapsed after first-line AML therapy (with or without hematopoietic stem cell transplant ) * Subject is positive for FLT3 mutation in bone marrow or whole blood as determined by the central lab * Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Subject is eligible for pre-selected salvage chemotherapy at the investigator's discretion Exclusion Criteria: * Subject has received prior treatment with other FLT3 inhibitors * Subject has AML that has relapsed after or is refractory to more than 1 line of therapy * Subject has an active uncontrolled infection * Subject is known to have human immunodeficiency virus infection * Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation
References
Publications (0)
Data not yet available
No reference posted for this study.