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A Pivotal Phase 3 Study of APG-2575 (Lisaftoclax) Combined With Azacytidine in the Treatment of Acute Myeloid Leukemia - Trial NCT06389292

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.

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NCT06389292
Phase 3
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06389292
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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

Study Focus

Acute Myeloid Leukemia

Lisaftoclax (APG-2575)

Interventional

drug

Sponsor & Location

Ascentage Pharma Group Inc.

Tianjin,Hangzhou, China

Timeline & Enrollment

Phase 3

May 01, 2024

Mar 26, 2029

486 participants

Primary Outcome

Overall Survival๏ผˆOS๏ผ‰

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 leukaemia
Acute myeloblastic leukaemia [AML]
Myeloid leukaemia, unspecified
Acute myelomonocytic leukaemia
Acute myeloid leukaemia with 11q23-abnormality

Data Source

ClinicalTrials.gov

NCT06389292

Non-Device Trial