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OncoMatch/Clinical Trials/NCT05133882

A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML

Is NCT05133882 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Clifutinib Besylate for acute myeloid leukemia, adult.

Phase 1/2RecruitingSunshine Lake Pharma Co., Ltd.NCT05133882Data as of May 2026

Treatment: Clifutinib BesylateThis is a multi-center open clinical study aimed at evaluating the efficacy and safety of Clifutinib Besylate combined with chemotherapy in newly-treated adult subjects with AML

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: FLT3 ITD

the extension phase requires the subject to be positive for the FLT3-ITD mutation

Excluded: BCR ABL fusion

BCR-ABL positive leukemia

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: FLT3 inhibitor

previously received FLT3 inhibitor

Cannot have received: chemotherapy or radiotherapy for other tumors

Diagnosed as secondary to AML due to previous chemotherapy or radiotherapy of other tumors

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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