^
Association details:
| Biomarker: | FLT3-ITD mutation |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | clifutinib (HEC73543) (FLT3 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Clinical Trial to Evaluate Clifutinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia(AML)
Excerpt:
...- Documented acute myeloid leukemia according to World Health Organization（WHO） criteria(excluding acute promyelocytic leukemia), with FLT3-ITD gene mutation,refractory after common or enhanced chemotherapy or relapse....
Trial ID:
Source:
Title:
A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML
Excerpt:
...the extension phase requires the subject to be positive for the FLT3-ITD mutation....
Trial ID:
Less C2 evidence
Source:
Title:
4281 Efficacy and Safety of Clifutinib, a Novel, Highly Selective, Oral FLT3 Inhibitor, in Patients with FLT3-Mutated Relapsed or Refractory Acute Myeloid Leukemia Updated Results from a Phase I Study
Published date:
11/02/2023
Excerpt:
This phase 1 study has demonstrated an acceptable safety profile and a significant anti-leukaemic activity of clifutinib in FLT3 mutant R/R AML, with the best response at the dose of 40 mg/day in FLT3-ITD(+)/TKD(-) AML.
Trial ID:
Source:
Title:
PRELIMINARY RESULTS OF A PHASE I STUDY OF CLIFUTINIB, A HIGHLY SELECTIVE, POTENT ORAL FLT-3 INHIBITOR, IN PATINETS WITH FLT3-MUTATED RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA
Published date:
05/12/2022
Excerpt:
Of 53 FLT3-ITD positive, evaluable subjects, CR/CRh rate was 17.0% (9/53), and CRc rate was 45.3% (24/53). Among subjects administered with Clifutinib 40 mg daily, the CR/CRh rate was 18.2% (6/33) with 3 patients achieved CR, median DOR of CR/CRh was 5.7 months, the CRc rate was 48.5% (16/33), and median OS was 7.4 months....Preliminary results of this phase 1 study demonstrated that Clifutinib has an acceptable safety profile and promising antitumor activity, especially at the dose of 40 mg daily.
Trial ID:
