OncoMatch/Clinical Trials/NCT06389292

A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia

Is NCT06389292 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including APG-2575(Lisaftoclax ) and Azacitidine for acute myeloid leukemia.

Phase 3RecruitingAscentage Pharma Group Inc.NCT06389292Data as of May 2026

Treatment: APG-2575(Lisaftoclax ) · Azacitidine — A global, multicenter, randomized, double-blind, placebo-controlled, phase III pivotal registration study, to evaluate the efficacy of APG-2575 (Lisaftoclax) combined with azacitidine (AZA) versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Excluded: ABL1 fusion

Excluded: BCR fusion

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Patients aged ≥70 years with ECOG score of 0-2, or those aged≥18 years and <70 years with ECOG score of 0-3

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: treatment for hematologic disorders

Previous treatment for hematologic disorders

Lab requirements

Blood counts

White blood cell ≤ 30×10^9/L

Kidney function

Adequate kidney function

Liver function

Adequate liver function

Cardiac function

NYHA Class ≤ 2

Adequate kidney function. White blood cell ≤ 30×10^9/L. Adequate liver function. Patients who has a cardiovascular disability status of New York Heart Association Class > 2 [excluded].

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

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