Higher-risk Myelodysplastic SyndromePhase 3NCT06641414

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

A Phase 3 study testing Lisaftoclax (APG-2575) and Azacitidine Injection in people with Higher-risk Myelodysplastic Syndrome, run by Ascentage Pharma Group Inc. at 155 sites in 18 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Higher-risk Myelodysplastic Syndrome
What is being tested?: Lisaftoclax (APG-2575) and Azacitidine Injection
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 490 participants
Where: 155 sitesin 18 countries
Study dates: 22 Jan 2025to Dec 2029
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Newly diagnosed higher-risk MDS.
ECOG score of ≤2.
Expected survival ≥ 3 months.
Adequate organ function.
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.
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.
Subjects are able to complete study procedures and follow-up examinations.

Who cannot join

Concomitant other malignancies or prior malignancies with disease-free intervals of less than 1 year at the time of signing the informed consent.
Have undergone hematopoietic stem cell transplantation.
Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug.
MDS or other conditions that cannot be administered enterally.
Any condition that the subject is deemed to be inappropriate to participate in this study after evaluation by the investigator.

Trial locations and contacts

155 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

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

+86-20-28068501

yzhai@ascentage.com

Qian Niu, M.D. contact

Qian.Niu@ascentage.com

Country

City, postcode or hospital

Sites recruiting now only

155 sites in 18 countries

United States40 sites, 40 recruiting

Ascentage Investigative Site
Aurora, Colorado, 80045
Recruiting
Ascentage Investigative Site
Austin, Texas, 78705
Recruiting
Ascentage Investigative Site
Baltimore, Maryland, 21201-1595
Recruiting
Ascentage Investigative Site
Birmingham, Alabama, 35294
Not yet recruiting
Ascentage Investigative Site
Charlotte, North Carolina, 28204
Recruiting
Ascentage Investigative Site
Charlottesville, Virginia, 22908
Recruiting
Ascentage Investigative Site
Chicago, Illinois, 60611
Recruiting
Ascentage Investigative Site
Cleveland, Ohio, 44195
Recruiting
Ascentage Investigative Site
Columbus, Ohio, 43210
Recruiting
Ascentage Investigative Site
Durham, North Carolina, 27705
Recruiting
Ascentage Investigative Site
Edmonds, Washington, 98026
Recruiting
Ascentage Investigative Site
Eugene, Oregon, 97401
Recruiting
Ascentage Investigative Site
Hackensack, New Jersey, 07601
Recruiting
Ascentage Investigative Site
Houston, Texas, 77054
Guillermo Garcia-Manero, M.D.
Recruiting
Ascentage Investigative Site
Indianapolis, Indiana, 46237
Recruiting
Ascentage
Iowa City, Iowa, 52242
Not yet recruiting
Ascentage Investigative Site
Issaquah, Washington, 98104
Recruiting
Ascentage Investigative Site
Jacksonville, Florida, 32224
Recruiting
Ascentage Investigative Site
Lincoln, Nebraska, 68506
Recruiting
Ascentage Investigative Site
Los Angeles, California, 90095
Recruiting
Ascentage Investigative Site
Louisville, Kentucky, 40202
Recruiting
Ascentage Investigative Site
Manassas, Virginia, 20110
Recruiting
Ascentage Investigative Site
Milwaukee, Wisconsin, 53266
Recruiting
Ascentage Investigative Site
Minneapolis, Minnesota, 55455
Recruiting
Ascentage Investigative Site
New York, New York, 10065
Recruiting
Ascentage Investigative Site
Norfolk, Virginia, 23502
Recruiting
Ascentage Investigative Site
Phoenix, Arizona, 85054
Recruiting
Ascentage Investigative Site
Pittsburgh, Pennsylvania, 15232
Recruiting
Ascentage Investigative Site
Providence, Rhode Island, 02903
Not yet recruiting
Ascentage Investigative Site
Rochester, Minnesota, 55905
Recruiting
Ascentage Investigative Site
Rochester, New York, 14642
Recruiting
Ascentage Investigative Site
Sacramento, California, 95817
Recruiting
Ascentage Investigative Site
San Diego, California, 92093
Recruiting
Ascentage Investigative Site
Seattle, Washington, 98104
Recruiting
Ascentage Investigative Site
Seattle, Washington, 98109
Recruiting
Ascentage Investigative Site
St Louis, Missouri, 63110
Recruiting
Ascentage Investigative Site
The Bronx, New York, 10467
Recruiting
Ascentage Investigative Site
Tyler, Texas, 75702
Recruiting
Ascentage Investigative Site
Waukesha, Wisconsin, 53188
Recruiting
Ascentage Investigative Site
Winston-Salem, North Carolina, 27103
Recruiting

Other trials in United States

Spain17 sites, 17 recruiting

Ascentage Investigative Site
Badalona, Spain, 08916
Recruiting
Ascentage Investigative Site
Barcelona, Spain, 08035
Recruiting
Ascentage Investigative Site
Barcelona, Spain, 08908
Recruiting
Ascentage Investigative Site
Cáceres, Spain, 10003
Recruiting
Ascentage Investigative Site
Girona, Spain, 17007
Recruiting
Ascentage Investigative Site
Madrid, Spain, 28007
Recruiting
Ascentage Investigative Site
Madrid, Spain, 28008
Recruiting
Ascentage Investigative Site
Madrid, Spain, 28033
Recruiting
Ascentage Investigative Site
Madrid, Spain, 28034
Recruiting
Ascentage Investigative Site
Madrid, Spain, 28046
Recruiting
Ascentage Investigative Site
Málaga, Spain, 29010
Recruiting
Ascentage Investigative Site
Ourense, Spain, 32005
Recruiting
Ascentage Investigative Site
Oviedo, Spain, 33011
Recruiting
Ascentage Investigative Site
Pamplona, Spain, 31008
Recruiting
Ascentage Investigative Site
Seville, Spain, 41013
Recruiting
Ascentage Investigative Site
Valencia, Spain, 46010
Recruiting
Ascentage Investigative Site
Valencia, Spain, 46064
Recruiting

Other trials in Spain

France13 sites, 13 recruiting

Ascentage Investigative Site
Angers, France, 49100
Recruiting
Ascentage Investigative Site
Le Mans, France, 72000
Recruiting
Ascentage Investigative Site
Limoges, France, 87000
Recruiting
Ascentage Investigative Site
Nantes, France, 44000
Recruiting
Ascentage Investigative Site
Nantes, France, 44277
Recruiting
Ascentage Investigative Site
Nice, France, 06202
Recruiting
Ascentage Investigative Site
Orléans, France, 45000
Recruiting
Ascentage Investigative Site
Paris, France, 75010
Recruiting
Ascentage Investigative Site
Pessac, France, 33604
Recruiting
Ascentage Investigative Site
Poitiers, France, 86000
Recruiting
Ascentage Investigative Site
Pontoise, France, 95300
Recruiting
Ascentage Investigative Site
Tours, France, 37044
Recruiting
Ascentage Investigative Site
Villejuif, France, 94800
Recruiting

Other trials in France

Italy13 sites, 13 recruiting

Ascentage Investigative Site
Candiolo, Italy, 10060
Recruiting
Ascentage Investigative Site
Ferrara, Italy, 44124
Recruiting
Ascentage Investigative Site
Florence, Italy, 50134
Recruiting
Ascentage Investigative Site
Meldola, Italy, 47014
Recruiting
Ascentage Investigative Site
Milan, Italy, 20141
Recruiting
Ascentage Investigative Site
Novara, Italy, 28100
Recruiting
Ascentage Investigative Site
Ravenna, Italy, 48121
Recruiting
Ascentage Investigative Site
Roma, Italy, 00133
Recruiting
Ascentage Investigative Site
Roma, Italy, 00144
Recruiting
Ascentage Investigative Site
Roma, Italy, 00161
Recruiting
Ascentage Investigative Site
Rozzano, Italy, 20089
Recruiting
Ascentage Investigative Site
Torino, Italy, 10128
Recruiting
Ascentage Investigative Site
Varese, Italy, 21100
Recruiting

Other trials in Italy

United Kingdom12 sites, 12 recruiting

Ascentage Investigative Site
Aberdeen, AB25 2ZN
Recruiting
Ascentage Investigative Site
Birmingham, B24 9SA
Recruiting
Ascentage Investigative Site
Boston, UK, PE21 9QS
Recruiting
Ascentage Investigative Site
Boston, PE21 9QS
Recruiting
Ascentage Investigative Site
Cardiff, CF14 4XW
Recruiting
Ascentage Investigative Site
Coventry, CV3 2DX
Recruiting
Ascentage Investigative Site
Dorchester, DT1 2JY
Recruiting
Ascentage Investigative Site
Exeter, EX2 5DW
Recruiting
Ascentage Investigative Site
Leeds, LS9 7TF
Recruiting
Ascentage Investigative Site
London, NW1 2PG
Recruiting
Ascentage Investigative Site
London, SE5 9RS
Recruiting
Ascentage Investigative Site
Manchester, M20 4BX
Recruiting

Other trials in United Kingdom

Australia10 sites, 10 recruiting

Ascentage Investigative Site
Blacktown, Australia, 2148
Recruiting
Ascentage Investigative Site
Cooloongup, Australia, 6168
Recruiting
Ascentage Investigative Site
Epping, Australia, 3076
Recruiting
Ascentage Investigative Site
Heidelberg, Australia, 3084
Recruiting
Ascentage Investigative Site
Kingswood, Australia, 2747
Recruiting
Ascentage Investigative Site
Liverpool, Australia, 2170
Not yet recruiting
Ascentage Investigative Site
Melbourne, Australia, 3004
Recruiting
Ascentage Investigative Site
Perth, Australia, 6000
Recruiting
Ascentage Investigative Site
Richmond, Australia, 3121
Recruiting
Ascentage Investigative Site
Waratah, Australia, 2298
Recruiting

Other trials in Australia

Germany8 sites, 8 recruiting

Ascentage Investigative Site
Berlin, Germany, 11203
Recruiting
Ascentage Investigative Site
Dresden, Germany, 01307
Recruiting
Ascentage Investigative Site
Dresden, Germany, 01307
Not yet recruiting
Ascentage Investigative Site
Düsseldorf, Germany, 40479
Recruiting
Ascentage Investigative Site
Halle, Germany, 06112
Recruiting
Ascentage Investigative Site
Leipzig, Germany, 04103
Recruiting
Ascentage Investigative Site
Stuttgart, Germany, 70376
Recruiting
Ascentage Investigative Site
Ulm, Germany, 89081
Not yet recruiting

Other trials in Germany

Greece7 sites, 7 recruiting

Ascentage Investigative Site
Alexandroupoli, Greece, 68100
Recruiting
Ascentage Investigative Site
Athens, Greece, 10676
Recruiting
Ascentage Investigative Site
Athens, Greece, 11527
Recruiting
Ascentage Investigative Site
Athens, Greece, 11528
Recruiting
Ascentage Investigative Site
Athens, Greece, 12462
Recruiting
Ascentage Investigative Site
Pátrai, Greece, 26443
Recruiting
Ascentage Investigative Site
Thessaloniki, Greece, 54636
Recruiting

Other trials in Greece

Belgium6 sites, 6 recruiting

Ascentage Investigative Site
Antwerp, 2030
Recruiting
Ascentage Investigative Site
Brasschaat, 2930
Recruiting
Ascentage Investigative Site
Bruges, 8000
Recruiting
Ascentage Investigative Site
Ghent, 9000
Recruiting
Ascentage Investigative Site
Leuven, 3001
Recruiting
Ascentage Investigative Site
Roeselare, 8800
Recruiting

Other trials in Belgium

Canada5 sites, 5 recruiting

Ascentage Investigative Site
Calgary, Alberta, AB T2N
Not yet recruiting
Ascentage Investigative Site
Montreal, Quebec, H1T 2M4
Not yet recruiting
Ascentage Investigative Site
Montreal, Quebec, H4A 3J1
Recruiting
Ascentage Investigative Site
Toronto, Ontario, M5G 2M9
Not yet recruiting
Ascentage Investigative Site
Vancouver, British Columbia, V6Z 1Y6
Not yet recruiting

Other trials in Canada

Bulgaria4 sites, 4 recruiting

Ascentage Investigative Site
Plovdiv, 4002
Recruiting
Ascentage Investigative Site
Sofia, 01750
Recruiting
Ascentage Investigative Site
Sofia, 01797
Recruiting
Ascentage Investigative Site
Sofia, 1431
Recruiting

Other trials in Bulgaria

Czechia4 sites, 4 recruiting

Ascentage Investigative Site
Brno, 62500
Recruiting
Ascentage Investigative Site
Hradec Králové, 50005
Recruiting
Ascentage Investigative Site
Ostrava, 708 52
Recruiting
Ascentage Investigative Site
Prague, 128 08
Recruiting

Other trials in Czechia

Hungary4 sites, 4 recruiting

Ascentage Investigative Site
Budapest, Hungary, 01088
Recruiting
Ascentage Investigative Site
Budapest, Hungary, 01097
Not yet recruiting
Ascentage Investigative Site
Debrecen, Hungary, 04032
Recruiting
Ascentage Investigative Site
Kaposvár, Hungary, 07400
Recruiting

Other trials in Hungary

Poland4 sites, 4 recruiting

Ascentage Investigative Site
Gdansk, Poland, 80-214
Recruiting
Ascentage Investigative Site
Lodz, Poland, 93-513
Recruiting
Ascentage Investigative Site
Olsztyn, Poland, 10228
Recruiting
Ascentage Investigative Site
Warsaw, Poland, 02-776
Recruiting

Other trials in Poland

Finland3 sites, 3 recruiting

Ascentage Investigative Site
Helsinki, Finland, 00290
Not yet recruiting
Ascentage Investigative S
Kuopio, Finland, 70210
Recruiting
Ascentage Investigative Site
Tampere, Finland, 33520
Recruiting

Other trials in Finland

Norway3 sites, 3 recruiting

Ascentage Investigative Site
Bergen, Norway, 05021
Recruiting
Ascentage Investigative Site
Oslo, Norway, 00372
Recruiting
Ascentage Investigative Site
Skien, Norway, 03710
Recruiting

Other trials in Norway

China1 site, 1 recruiting

Ascentage Investigative Site
Beijing, Beijing Municipality, 100033
Recruiting

Other trials in China

Sweden1 site, 1 recruiting

Ascentage Investigative Site
Örebro, Sweden, 70185
Recruiting

Other trials in Sweden

About this study

Official title: A Global Multicenter, Double-blind, Randomized, Registrational Phase 3 Study of Lisaftoclax (APG-2575) in Combination With Azacitidine (AZA) in Patients With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4).

Read the 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.

Conditions: Higher-risk Myelodysplastic Syndrome
Being tested: Lisaftoclax (APG-2575), Azacitidine Injection, Placebo
Keywords: Higher-risk Myelodysplastic Syndrome, Lisaftoclax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lisaftoclax (APG-2575)Drug
QD, oral administration.
Azacitidine InjectionDrug
QD, hypodermic or intravenous injection.
PlaceboOther
QD, oral administration.

Study groups in NCT06641414
Study group	Role	What they receive
Lisaftoclax (APG-2575) combined with Azacitidine	Experimental	Not described Receives: Drug: Lisaftoclax (APG-2575); Drug: Azacitidine Injection
Placebo combined with Azacitidine	Active comparator	Drug: azacitidine injection QD: hypodermic or intravenous injection Receives: Drug: Azacitidine Injection; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival（OS）
The primary endpoint was overall survival (OS), defined as the time from the date of randomization to the date of death of any cause.
Measured: Up to 5 years

Secondary outcomes (1)

Safety evaluation based on the adverse event concurrence
Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.
Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 2025Dec 2029

First posted15 Oct 2024
Study start22 Jan 2025
Primary completionJun 2029 (estimated)
Study completionDec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Higher-risk Myelodysplastic SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 490 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06641414
Sponsor's protocol ID: APG2575MG301
Status last verified: Oct 2026
First submitted: 12 Oct 2024
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Interested in taking part?

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

+86-20-28068501

yzhai@ascentage.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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