NCT06389292

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

Name: Clinical Trial NCT06389292
Creator: Ascentage Pharma Group Inc.
Keywords: Acute Myeloid Leukemia, Lisaftoclax (APG-2575), Phase 3, drug, clinical trial, China

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

Ascentage Pharma Group Inc.·Phase 3·ClinicalTrials.gov·drugNot yet recruiting

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Study focus

Disease/Condition: Acute Myeloid Leukemia
Drug/Device/Intervention: Lisaftoclax (APG-2575)
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Ascentage Pharma Group Inc.
Location: Tianjin,Hangzhou, China

Timeline & enrollment

Phase: Phase 3
Start date: May 01, 2024
End date: Mar 26, 2029
Enrollment: 486 participants

Primary outcome

Overall Survival（OS）

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.

ICD-10 classifications

Myeloid leukaemiaAcute myeloblastic leukaemia [AML]Myeloid leukaemia, unspecifiedAcute myelomonocytic leukaemiaAcute myeloid leukaemia with 11q23-abnormality

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06389292
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06389292 through Pure Global AI's free database. This Phase 3 trial is sponsored by Ascentage Pharma Group Inc. and is currently Not yet recruiting. The study focuses on Acute Myeloid Leukemia. Target enrollment is 486 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.