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

Trial Details

NCT ID

NCT05133882

Phase

PHASE1 / PHASE2

Sponsor

Sunshine Lake Pharma Co., Ltd.

Status

RECRUITING

Cancer Type

Leukemia

Interventions

• Clifutinib Besylate

Locations (sample)

• Hanzhou, Zhejiang, China

Key Eligibility Criteria

• Cohort 1: 18 years old ≤ age ≤65 years old;Cohort 2: The dose escalation trial only included AML subjects aged ≥60 years; the extended trial includ…
• It can be primary AML or AML secondary to MDS, and has not been treated; the extension phase requires the subject to be positive for the FLT3-ITD m…
• The ECOG score according to the requirements of different groups is as follows: Cohort 1: 0\~1 points; Cohort 2: Age ≥60 years old: 0\~2 points; Ag…
• Expected survival time ≥ 12 weeks. 5. Subjects must have adequate organ function. 6.subjects voluntarily participated in the study, and signed a wr…

For full eligibility, visit ClinicalTrials.gov.

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