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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 (Jun 2026). This Phase 1/2 trial studies Clifutinib Besylate for acute myeloid leukemia, adult.

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

Treatments studied

Other

Clifutinib Besylate

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.

Frequently asked questions

Is NCT05133882 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require FLT3?

Yes, FLT3 ITD is a required biomarker for enrollment.

Are patients with BCR alterations eligible?

No. BCR ABL fusion is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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