Acute Myeloid Leukemia
Conditions
Keywords
APG -2575, Lisaftoclax
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 (APG-2575) + AZA' or the control group 'placebo+ AZA'.
Interventions
DRUGAPG-2575(Lisaftoclax )
QD, oral administration, every 28 days for a dosing cycle.
OTHERPlacebo
QD, oral administration, every 28 days for a dosing cycle.
QD, subcutaneous or intravenous injection, D1-7 in 28-day cycle.
Sponsors
Ascentage Pharma Group Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must have newly diagnosed AML that meets the criteria for acute myeloid leukemia (AML) and 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 is uncontrolled and requires systemic treatment. 4. Use of strong inducers of CYP3A4 within 7 days prior to the first dose of the investigational drug, and/or use of moderate to strong inhibitors of CYP3A4 within 7 days or 3-5 half-lives (whichever is longer) prior to the first dose of the investigational 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 in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival（OS） | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Objective Response Rate (ORR) | Up to 5 years | ORR is defined as the proportion of patients who have achieved CR, CRi, CRh, MLFS or PR. |
| Safety evaluation based on the adverse event concurrence | Up to 5 years | Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated. |
Countries
China, Russia
Contacts
Primary ContactYifan Zhai, M.D., Ph.D.
Backup ContactLihui Liu, M.D.
Outcome results
None listed