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

Ascentage Pharma Group

Status and phase: Enrolling; Phase 3

Conditions: Acute Myeloid Leukemia

Treatments: Other: Placebo; Drug: Lisaftoclax (APG-2575); Drug: Azacitidine Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06389292

APG2575AG301

Details and patient eligibility

About

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.

Full description

The newly diagnosed acute myeloid leukemia, who are not eligible for standard induction chemotherapy, will be randomized to the investigational group (Lisaftoclax+ AZA) or the control group (placebo+ AZA).

Enrollment: 486 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must have newly diagnosed AML that meets the criteria for acute myeloid leukemia (AML) and be ineligible for standard chemotherapy.
2. Life expectancy of ≥3 months.
3. Be able to accept oral administration.
4. Patients aged ≥70 years with ECOG score of 0-2, or those aged≥18 years and <70 years with ECOG score of 0-3.
5. Adequate kidney function.
6. White blood cell ≤ 30×10^9/L.
7. Adequate liver function.
8. Men, women with childbearing potential, and their partners voluntarily use contraception that researchers consider effective.
9. Be able to understand and voluntarily sign written informed consent.
10. Patients must be willing and able to complete study procedures and follow-up examinations.

Exclusion criteria

1. The patient was diagnosed with acute promyelocytic leukemia or AML (BCR-ABL1 positive.
2. Active leukemic infiltration of the central nervous system.
3. Active infection that requires systemic treatment.
4. Use of a moderate or strong inducer and/or inhibitor of CYP3A4 within 7 days prior to first dose of the study drug.
5. Previous treatment for hematologic disorders.
6. Patients who has a cardiovascular disability status of New York Heart Association Class > 2.
7. Patients have malabsorption syndrome or other conditions that cannot be administered through the gastrointestinal tract or affect drug absorption.
8. Patients had a history of other malignancies prior to study initiation.
9. Any other circumstances or conditions, at the discretion of the investigator, make the patient unsuitable to participate the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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486 participants in 2 patient groups

Lisaftoclax (APG-2575) combined with Azacitidine

Experimental group

Treatment:

Drug: Azacitidine Injection

Drug: Lisaftoclax (APG-2575)

Placebo combined with Azacitidine

Active Comparator group

Treatment:

Drug: Azacitidine Injection

Other: Placebo