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 (Jun 2026). This Phase 3 trial studies multiple treatments including APG-2575(Lisaftoclax ) and Azacitidine for acute myeloid leukemia.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
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
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.
Frequently asked questions
Is NCT06389292 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.
Are patients with ABL1 alterations eligible?
No. ABL1 fusion is an exclusion criterion.
Are patients with BCR alterations eligible?
No. BCR 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.
Check if I qualifyRelated pages