A Pivotal Phase 3 Study of APG-2575 (Lisaftoclax) Combined With Azacytidine in the Treatment of Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:

An International, Multicenter, Randomized, Double-blind, Phase 3, Pivotal Registration Clinical Study of APG-2575 (Lisaftoclax) in Combination With Azacytidine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06389292
• Other study ID #: APG2575AG301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2024
• Est. completion date: March 26, 2029

Study information

• Verified date: April 2024
• Source: Ascentage Pharma Group Inc.
• Contact: Yifan Zhai, M.D., Ph.D.
• Phone: +86-20-28068501
• Email: yzhai[@]ascentage.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An international 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 486
• Est. completion date: March 26, 2029
• Est. primary completion date: May 25, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Lisaftoclax (APG-2575)
QD, oral administration, every 28 days for a dosing cycle.

Other:
• Placebo
QD, oral administration, every 28 days for a dosing cycle.

Drug:
• Azacitidine Injection
QD, hypodermic or intravenous injection, D1-7 in 28-day cycle.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Hematology Hospital of the Chinese Academy of Medical Sciences	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Ascentage Pharma Group Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival(OS)	The primary endpoint was overall survival (OS), defined as the time from the date of randomization to the date of death of any cause.	Up to 5 years
Secondary	Percentage of Participants with Objective Response Rate (ORR)	ORR is defined as the proportion of patients who have achieved CR, CRi, CRh, MLFS or PR.	Up to 5 years
Secondary	Safety evaluation based on the adverse event concurrence	Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.	Up to 5 years