Clinical trial NCT06389292: A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia
Official title: A Global, Multicenter, Randomized, Double-blind, Phase 3 Pivotal Registrational Clinical Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (GLORA-3)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: APG -2575
Lisaftoclax
Lead sponsor: Ascentage Pharma Group Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival（OS）
timeFrame: Up to 5 years
Secondary outcomes:
measure: Percentage of Participants with Objective Response Rate (ORR)
timeFrame: Up to 5 years
measure: Safety evaluation based on the adverse event concurrence
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Hematology Hospital of the Chinese Academy of Medical Sciences
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Hematology Hospital of the Chinese Academy of Medical Sciences
name: Jianxiang Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang University
name: Jie Jin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: