Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Azacitidine

Antimetabolites

Enzyme Inhibitors

QD, oral administration, every 28 days for a dosing cycle.

Lisaftoclax (APG-2575)

Placebo

QD, hypodermic or intravenous injection, D1-7 in 28-day cycle.

Azacitidine Injection

Yifan Zhai, M.D., Ph.D.

Lihui Liu, M.D.

Hui Wei, M.D.

Jie Jin, M.D.

Jianxiang Wang, M.D.

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.

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).

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

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

The primary endpoint was overall survival (OS), defined as the time from the date of randomization to the date of death of any cause.

ORR is defined as the proportion of patients who have achieved CR, CRi, CRh, MLFS or PR.

Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.

Ascentage Pharma Group Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Pivotal Phase 3 Study of APG-2575 (Lisaftoclax) Combined With Azacytidine in the Treatment of Acute Myeloid Leukemia	NCT06389292	Acute Myeloid L...	Lisaftoclax (AP... Placebo Azacitidine Inj...	18 Years -	Ascentage Pharma Group Inc.
A Pivotal Phase 3 Study of APG-2575 (Lisaftoclax) Combined With Azacytidine in the Treatment of Acute Myeloid Leukemia	NCT06389292	Acute Myeloid L...	Lisaftoclax (AP... Placebo Azacitidine Inj...	18 Years -	Ascentage Pharma Group Inc.

Spots Global Cancer Trial Database for lisaftoclax

Every month we try and update this database with for lisaftoclax cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lisaftoclax

Every month we try and update this database with for lisaftoclax cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lisaftoclax cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.