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NCT06641414PHASE3Recruiting

Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).

Ascentage Pharma Group Inc.

Start Date

1/22/2025

Completion Date

12/1/2029

Summary

A global multicenter, randomized, double-blind, placebo-controlled, pivotal phase III study. To evaluate overall survival (OS) of lisaftoclax (APG-2575) combined with azacitidine (AZA) vs. placebo combined with azacitidine in newly diagnosed patients with HR-MDS.

Detailed Description

This study intends to enroll patients with HR-MDS to receive the therapy of lisaftoclax (APG-2575) combined with azacitidine (AZA) or placebo combined with azacitidine.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Newly diagnosed higher-risk MDS. 2. ECOG score of ≤2. 3. Expected survival ≥ 3 months. 4. Adequate organ function. 5. Female subjects of potential childbearing potential have a negative urine or serum pregnancy test before dosing. Subjects of childbearing potential as well as their partners voluntarily use contraception deemed effective by the investigator during the treatment period and for at least six months after the last dose of study drug. 6. Able to understand and voluntarily sign a written informed consent form, which must be signed prior to the performance of any trial-specified study procedures. 7. Subjects are able to complete study procedures and follow-up examinations. Exclusion Criteria: 1. Concomitant other malignancies or prior malignancies with disease-free intervals of less than 1 year at the time of signing the informed consent. 2. Have undergone hematopoietic stem cell transplantation. 3. Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug. 4. MDS or other conditions that cannot be administered enterally. 5. Any condition that the subject is deemed to be inappropriate to participate in this study after evaluation by the investigator.

Interventions

DRUG

Lisaftoclax (APG-2575)

DRUG

Azacitidine Injection

OTHER

Placebo

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Conditions

Higher-risk Myelodysplastic Syndrome

Locations

Ascentage Investigative Site

Birmingham, Alabama 35294

United States

Ascentage Investigative Site

Phoenix, Arizona 85054

United States

Ascentage Investigative Site

Los Angeles, California 90095

United States

Ascentage Investigative Site

Sacramento, California 95817

United States

Ascentage Investigative Site

San Diego, California 92093

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Ascentage Investigative Site

Aurora, Colorado 80045

United States

Ascentage Investigative Site

Jacksonville, Florida 32224

United States

Ascentage Investigative Site

Chicago, Illinois 60611

United States

Ascentage Investigative Site

Indianapolis, Indiana 46237

United States

Ascentage

Iowa City, Iowa 52242

United States

Ascentage Investigative Site

Louisville, Kentucky 40202

United States

Ascentage Investigative Site

Baltimore, Maryland 21201-1595

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Ascentage Investigative Site

Minneapolis, Minnesota 55455

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Ascentage Investigative Site

Rochester, Minnesota 55905

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Ascentage Investigative Site

St Louis, Missouri 63110

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Ascentage Investigative Site

Lincoln, Nebraska 68506

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Ascentage Investigative Site

Hackensack, New Jersey 07601

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Ascentage Investigative Site

New York, New York 10065

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Ascentage Investigative Site

Rochester, New York 14642

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Ascentage Investigative Site

The Bronx, New York 10467

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Ascentage Investigative Site

Charlotte, North Carolina 28204

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Ascentage Investigative Site

Durham, North Carolina 27705

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Ascentage Investigative Site

Winston-Salem, North Carolina 27103

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Ascentage Investigative Site

Cleveland, Ohio 44195

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Ascentage Investigative Site

Columbus, Ohio 43210

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Ascentage Investigative Site

Eugene, Oregon 97401

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Ascentage Investigative Site

Pittsburgh, Pennsylvania 15232

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Ascentage Investigative Site

Providence, Rhode Island 02903

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Ascentage Investigative Site

Austin, Texas 78705

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Ascentage Investigative Site

Houston, Texas 77054

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Ascentage Investigative Site

Tyler, Texas 75702

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Ascentage Investigative Site

Charlottesville, Virginia 22908

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Manassas, Virginia 20110

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Norfolk, Virginia 23502

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Edmonds, Washington 98026

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Issaquah, Washington 98104

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Seattle, Washington 98104

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Ascentage Investigative Site

Seattle, Washington 98109

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Milwaukee, Wisconsin 53266

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Waukesha, Wisconsin 53188

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Blacktown, Australia 2148

Australia

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Cooloongup, Australia 6168

Australia

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Epping, Australia 3076

Australia

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Heidelberg, Australia 3084

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Kingswood, Australia 2747

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Liverpool, Australia 2170

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Melbourne, Australia 3004

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Perth, Australia 6000

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Richmond, Australia 3121

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Waratah, Australia 2298

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Antwerp, 2030

Belgium

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Brasschaat, 2930

Belgium

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Bruges, 8000

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Ghent, 9000

Belgium

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Leuven, 3001

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Roeselare, 8800

Belgium

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Plovdiv, 4002

Bulgaria

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Sofia, 01750

Bulgaria

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Sofia, 01797

Bulgaria

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Sofia, 1431

Bulgaria

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Calgary, Alberta AB T2N

Canada

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Vancouver, British Columbia V6Z 1Y6

Canada

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Toronto, Ontario M5G 2M9

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Montreal, Quebec H1T 2M4

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Montreal, Quebec H4A 3J1

Canada

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Beijing, Beijing Municipality 100033

China

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Brno, 62500

Czechia

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Hradec Králové, 50005

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Ostrava, 708 52

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Prague, 128 08

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Helsinki, Finland 00290

Finland

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Kuopio, Finland 70210

Finland

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Tampere, Finland 33520

Finland

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Angers, France 49100

France

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Le Mans, France 72000

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Limoges, France 87000

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Nantes, France 44000

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Nantes, France 44277

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Nice, France 06202

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Orléans, France 45000

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Paris, France 75010

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Pessac, France 33604

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Poitiers, France 86000

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Pontoise, France 95300

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Tours, France 37044

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Villejuif, France 94800

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Berlin, Germany 11203

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Dresden, Germany 01307

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Dresden, Germany 01307

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Düsseldorf, Germany 40479

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Halle, Germany 06112

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Leipzig, Germany 04103

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Stuttgart, Germany 70376

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Ulm, Germany 89081

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Alexandroupoli, Greece 68100

Greece

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Athens, Greece 10676

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Athens, Greece 11527

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Athens, Greece 11528

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Athens, Greece 12462

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Pátrai, Greece 26443

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Thessaloniki, Greece 54636

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Budapest, Hungary 01088

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Budapest, Hungary 01097

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Debrecen, Hungary 04032

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Kaposvár, Hungary 07400

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Candiolo, Italy 10060

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Ferrara, Italy 44124

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Florence, Italy 50134

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Meldola, Italy 47014

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Milan, Italy 20141

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Novara, Italy 28100

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Ravenna, Italy 48121

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Roma, Italy 00133

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Roma, Italy 00144

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Roma, Italy 00161

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Rozzano, Italy 20089

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Torino, Italy 10128

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Varese, Italy 21100

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Bergen, Norway 05021

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Oslo, Norway 00372

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Skien, Norway 03710

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Gdansk, Poland 80-214

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Lodz, Poland 93-513

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Olsztyn, Poland 10228

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Warsaw, Poland 02-776

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Badalona, Spain 08916

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Barcelona, Spain 08035

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Barcelona, Spain 08908

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Cáceres, Spain 10003

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Girona, Spain 17007

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Madrid, Spain 28007

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Madrid, Spain 28008

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Madrid, Spain 28033

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Madrid, Spain 28034

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Madrid, Spain 28046

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Málaga, Spain 29010

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Ourense, Spain 32005

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Oviedo, Spain 33011

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Pamplona, Spain 31008

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Seville, Spain 41013

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Ascentage Investigative Site

Valencia, Spain 46010

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Ascentage Investigative Site

Valencia, Spain 46064

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Ascentage Investigative Site

Örebro, Sweden 70185

Sweden

Ascentage Investigative Site

Boston, UK PE21 9QS

United Kingdom

Ascentage Investigative Site

Aberdeen, AB25 2ZN

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Birmingham, B24 9SA

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Boston, PE21 9QS

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Cardiff, CF14 4XW

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Coventry, CV3 2DX

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Dorchester, DT1 2JY

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Exeter, EX2 5DW

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Leeds, LS9 7TF

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London, NW1 2PG

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Ascentage Investigative Site

London, SE5 9RS

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Ascentage Investigative Site

Manchester, M20 4BX

United Kingdom