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

April 26, 2024 updated by: Ascentage Pharma Group Inc.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

486

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300020
        • Hematology Hospital of the Chinese Academy of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Hui Wei, M.D.
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
        • Contact:
          • Phone Number: 0571-87236896
        • Principal Investigator:
          • Jie Jin, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lisaftoclax (APG-2575) combined with Azacitidine
Drug: Lisaftoclax (APG-2575)
QD, oral administration, every 28 days for a dosing cycle.
Drug: Azacitidine Injection
QD, hypodermic or intravenous injection, D1-7 in 28-day cycle.
Active Comparator: Placebo combined with Azacitidine
Drug: Azacitidine Injection
QD, hypodermic or intravenous injection, D1-7 in 28-day cycle.
Other: Placebo
QD, oral administration, every 28 days for a dosing cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival（OS）
Time Frame: Up to 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Objective Response Rate (ORR)
Time Frame: Up to 5 years
ORR is defined as the proportion of patients who have achieved CR, CRi, CRh, MLFS or PR.
Up to 5 years
Safety evaluation based on the adverse event concurrence
Time Frame: Up to 5 years
Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascentage Pharma Group Inc.

Investigators

  • Principal Investigator: Jianxiang Wang, M.D., Hematology Hospital of the Chinese Academy of Medical Sciences
  • Principal Investigator: Jie Jin, M.D., Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 25, 2028

Study Completion (Estimated)

March 26, 2029

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APG2575AG301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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