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Trial Title:
A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacytidine in the Treatment of Acute Myeloid Leukemia
NCT ID:
NCT06389292
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Conditions: Keywords:
APG -2575
Lisaftoclax
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Lisaftoclax (APG-2575)
Description:
QD, oral administration, every 28 days for a dosing cycle.
Arm group label:
Lisaftoclax (APG-2575) combined with Azacitidine
Intervention type:
Other
Intervention name:
Placebo
Description:
QD, oral administration, every 28 days for a dosing cycle.
Arm group label:
Placebo combined with Azacitidine
Intervention type:
Drug
Intervention name:
Azacitidine Injection
Description:
QD, hypodermic or intravenous injection, D1-7 in 28-day cycle.
Arm group label:
Lisaftoclax (APG-2575) combined with Azacitidine
Arm group label:
Placebo combined with Azacitidine
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.
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).
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hematology Hospital of the Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Wei, M.D.
Phone:
022-23909120
Email:
weihui@ihcams.ac.cn
Investigator:
Last name:
Hui Wei, M.D.
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Jin, M.D.
Email:
jiej0503@163.com
Contact backup:
Phone:
0571-87236896
Investigator:
Last name:
Jie Jin, M.D.
Email:
Principal Investigator
Start date:
June 11, 2024
Completion date:
March 26, 2029
Lead sponsor:
Agency:
Ascentage Pharma Group Inc.
Agency class:
Industry
Source:
Ascentage Pharma Group Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06389292
