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CLL/SLLPhase 3NCT06104566

Global Trial in APG2575 for Patients With CLL/SLL

A Phase 3 study testing lisaftoclax +BTK inhibitor and BTK inhibitor in people with CLL/SLL, run by Ascentage Pharma Group Inc. at 135 sites in 19 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

This is a global multicenter, open label, randomized, registrational phase III study to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL/SLL patients who previously treated with BTK inhibitors Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
CLL/SLL
What is being tested?
lisaftoclax +BTK inhibitor and BTK inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
135 sitesin 19 countries
Study dates
20 Dec 2023to 31 Oct 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Patients that have documented CLL/SLL who meet iwCLL 2018 criteria for CLL treatment guidelines are eligible for treatment and must be receiving BTKi monotherapy for at least 12 months
  • ECOG Performance Status grade 0-2
  • Adequate bone marrow function independent of growth factor or transfusion support within 2 weeks of screening initiation as follows:
  • Absolute neutrophil count ≥ 1.0 × 109/L
  • Platelet counts ≥ 75 × 109/L; in cases of thrombocytopenia
Show all 16Show fewer
  • Total hemoglobin ≥ 9 g/dL,
  • Adequate renal function
  • Creatinine clearance must be > 50 ml/min directly measured with 24hr urine collection or calculated according to the modified formula of Cockcroft and Gault (for men: GFR ≈ ((140 - age) x actual body weight)/(72 x creatinine), for women x 0.85) or an equally accurate method.
  • For patients with creatinine values within the normal range, the calculation of clearance is not necessary. Dehydrated patients with an estimated creatinine clearance less than 50 ml/min may be eligible if a repeat estimate after adequate hydration is > 50 ml/min.
  • Adequate liver function as indicated by:
  • Total bilirubin ≤ 1.5 x ULN, except patients with known Gilbert's Syndrome
  • Aspartate aminotransferase (AST) ≤ 2.5 x the institutional ULN value
  • Alanine aminotransferase (ALT) ≤ 2.5 x the institutional ULN value,
  • International normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT) ≤ 1.5×ULN.
  • Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements

Who cannot join

None listed.

Trial locations and contacts

135 sites in 19 countries. Contact the study team or a site near you to ask about taking part.

Shanthi Marur, MD contact

3017925062

shanthi.marur@ascentage.com

Yifan Zhai, MD contact

301-549-6188

yzhai@ascentage.com

135 sites in 19 countries

China19 sites, 19 recruiting

  • Ascentage Investigative Site

    Beijing, Beijing Municipality, 100005

    Recruiting

  • Ascentage Investigative Site

    Binzhou, Shandong, 256600

    Recruiting

  • Ascentage Investigative Site

    Chenzhou, Hunan, 423000

    Recruiting

  • Ascentage Investigative Site

    Foshan, Guangdong, 528000

    Recruiting

  • Ascentage Investigative Site

    Fuzhou, Fujian, 350001

    Recruiting

  • Ascentage Investigative Site

    Guangzhou, Guangdong, 510050

    Recruiting

  • Ascentage Investigative Site

    Guangzhou, 510090

    Recruiting

  • Ascentage Investigative Site

    Hefei, Anhui, 230031

    Recruiting

  • Ascentage Investigative Site

    Luzhou, Sichuan, 646099

    Recruiting

  • Ascentage Investigative Site

    Nanchang, Jiangxi, 330008

    Recruiting

  • Ascentage Investigative Site

    Nanjing, Jiangsu, 210029

    Recruiting

  • Ascentage Investigative Site

    Nanning, Guangxie, 530022

    Recruiting

  • Ascentage Investigative Site

    Suzhou, Jiangsu, 215026

    Recruiting

  • Ascentage Investigative Site

    Taiyuan, Shanxi, 030013

    Recruiting

  • Ascentage Investigative Site

    Wuhan, Hubei, 430022

    Recruiting

  • Ascentage Investigative Site

    Wuxi, Jiangsu, 214023

    Recruiting

  • Ascentage Investigative Site

    Xi'an, Shaanxi, 710061

    Recruiting

  • Ascentage Investigative Site

    Yibin, Sichuan, 644099

    Recruiting

  • Ascentage Investigative Site

    Zhengzhou, Henan, 450003

    Recruiting

Other trials in China

India18 sites, 18 recruiting

  • Ascentage Investigative Site

    Bangalore, Karnataka, 560027

    Recruiting

  • Ascentage Investigative Site

    Delhi, National Capital Territory of Delhi, 110085

    Recruiting

  • Ascentage Investigative Site

    Gandhinagar, Gujarat, 382428

    Recruiting

  • Ascentage Investigative Site

    Gurugramam, Haryana, 122001

    Recruiting

  • Ascentage Investigative Site

    Gurugramam, Haryana, 122002

    Recruiting

  • Ascentage Investigative Site

    Hyderabad, Telangana, 500033

    Recruiting

  • Ascentage Investigative Site

    Jhajjar, Haryana, 124105

    Recruiting

  • Ascentage Investigative Site

    Kolkata, West Bengal, 700014

    Recruiting

  • Ascentage Investigative Site

    Kolkata, West Bengal, 700054

    Recruiting

  • Ascentage Investigative Site

    Madurai, Tamil Nadu, 625020

    Recruiting

  • Ascentage Investigative Site

    Mysuru, Karnataka, 570023

    Recruiting

  • Ascentage Investigative Site

    Navi Mumbai, Maharashtra, 400614

    Recruiting

  • Ascentage Investigative Site

    New Delhi, New Delhi, 110017

    Recruiting

  • Ascentage Investigative Site

    New Delhi, New Delhi, 110029

    Recruiting

  • Ascentage Investigative Site

    New Delhi, New Delhi, 110076

    Recruiting

  • Ascentage Investigative Site

    New Delhi, New, 110017

    Recruiting

  • Ascentage Investigative Site

    Puducherry, 605006

    Recruiting

  • Ascentage Investigative Site

    Pune, Maharashtra, 411001

    Recruiting

Other trials in India

Italy17 sites, 17 recruiting

  • Ascentage Investigative Site

    Aviano, 33081

    Recruiting

  • Ascentage Investigative Site

    Brescia, 25123

    Recruiting

  • Ascentage Investigative Site

    Cona, 44124

    Recruiting

  • Ascentage Investigative Site

    Genova, 16132

    Recruiting

  • Ascentage Investigative Site

    Lecce, 73100

    Recruiting

  • Ascentage Investigative Site

    Meldola, 47014

    Recruiting

  • Ascentage Investigative Site

    Milan, 20141

    Recruiting

  • Ascentage Investigative Site

    Milan, 20132

    Recruiting

  • Ascentage Investigative Site

    Padova, 35122

    Recruiting

  • Ascentage Investigative Site

    Piacenza, 29121

    Recruiting

  • Ascentage Investigative Site

    Ravenna, 48121

    Recruiting

  • Ascentage Investigative Site

    Reggio Emilia, 42123

    Recruiting

  • Ascentage Investigative Site

    Rimini, 47923

    Recruiting

  • Ascentage Investigative Site

    Roma, 00128

    Recruiting

  • Ascentage Investigative Site

    Roma, 00168

    Recruiting

  • Ascentage Investigative Site

    Torino, 10126

    Recruiting

  • Ascentage Investigative Site

    Udine, 33100

    Recruiting

Other trials in Italy

Russia12 sites

  • Ascentage Investigative Site

    Kaluga, 246007

    Active, not recruiting

  • Ascentage Investigative Site

    Kazan', 420029

    Active, not recruiting

  • Ascentage Investigative Site

    Kirov, Kirov Oblast, 610027

    Active, not recruiting

  • Ascentage Investigative Site

    Moscow, 115522

    Active, not recruiting

  • Ascentage Investigative Site

    Moscow, 123182

    Active, not recruiting

  • Ascentage Investigative Site

    Moscow, 125284

    Active, not recruiting

  • Ascentage Investigative Site

    Petrozavodsk, 185019

    Active, not recruiting

  • Ascentage Investigative Site

    Saint Petersburg, Kaluga Oblast, 248008

    Active, not recruiting

  • Ascentage Investigative Site

    Saint Petersburg, 197022

    Active, not recruiting

  • Ascentage Investigative Site

    Saint Petersburg, 197341

    Active, not recruiting

  • Ascentage Investigative Site

    Sochi, 354057

    Active, not recruiting

  • Ascentage Investigative Site

    Syktyvkar, 167904

    Active, not recruiting

Other trials in Russia

United States11 sites, 11 recruiting

  • Ascentage Investigative Site

    Anaheim, California, 92805

    Recruiting

  • Ascentage Investigative Site

    Ann Arbor, Michigan, 48109

    Recruiting

  • Ascentage Investigative Site

    Boston, Massachusetts, 02215

    Recruiting

  • Ascentage Investigative Site

    Greenville, North Carolina, 27834

    Recruiting

  • Ascentage Investigative Site

    Houston, Texas, 77030

    Nitin Jain, MD

    Recruiting

  • Ascentage Investigative Site

    Jacksonville, Florida, 32224

    Recruiting

  • Ascentage Investigative Site

    Kingswood, Texas, 77339

    Recruiting

  • Ascentage Investigative Site

    Miami Beach, Florida, 33140

    Recruiting

  • Ascentage Investigative Site

    Peoria, Illinois, 61615

    Recruiting

  • Ascentage Investigative Site

    Richmond, Virginia, 23298

    Recruiting

  • Ascentage Investigative Site

    Tuscon, Arizona, 85742

    Recruiting

Other trials in United States

France11 sites, 11 recruiting

  • Ascentage Investigative Site

    Clermont-Ferrand, 63000

    Recruiting

  • Ascentage Investigative Site

    Le Mans, 72037

    Recruiting

  • Ascentage Investigative Site

    Lyon, 69373

    Recruiting

  • Ascentage Investigative Site

    Nantes, 44000

    Recruiting

  • Ascentage Investigative Site

    Nantes, 44277

    Recruiting

  • Ascentage Investigative Site

    Nîmes, 30029

    Recruiting

  • Ascentage Investigative Site

    Orléans, 45100

    Recruiting

  • Ascentage Investigative Site

    Poitiers, 86000

    Recruiting

  • Ascentage Investigative Site

    Pontoise, 95300

    Recruiting

  • Ascentage Investigative Site

    Strasbourg, 67091

    Recruiting

  • Ascentage Investigative Site

    Tours, 37000

    Recruiting

Other trials in France

United Kingdom9 sites, 9 recruiting

  • Ascentage Investigative Site

    Birmingham, B15 2GW

    Recruiting

  • Ascentage Investigative Site

    Bournemouth, BH7 7DW

    Recruiting

  • Ascentage Investigative Site

    Liverpool, L7 8YA

    Recruiting

  • Ascentage Investigative Site

    London, SW3 6JJ

    Recruiting

  • Ascentage Investigative Site

    Manchester, M20 4BX

    Recruiting

  • Ascentage Investigative Site

    Stoke-on-Trent, ST4 6QG

    Recruiting

  • Ascentage Investigative Site

    Swansea, SA2 8QA

    Recruiting

  • Ascentage Investigative Site

    West Bromwich, B71 4HJ

    Recruiting

  • Ascentage Investigative Site

    Wolverhampton, WV10 0QP

    Recruiting

Other trials in United Kingdom

Belgium5 sites, 5 recruiting

  • Ascentage Investigative Site

    Ghent, 9000

    Recruiting

  • Ascentage Investigative Site

    La Louvière, 7100

    Recruiting

  • Ascentage Investigative Site

    Leuven, 3000

    Recruiting

  • Ascentage Investigative Site

    Ottignies, 1349

    Recruiting

  • Ascentage Investigative Site

    Roeselare, 8800

    Recruiting

Other trials in Belgium

Israel5 sites, 5 recruiting

  • Ascentage Investigative Site

    Haifa, 31048

    Recruiting

  • Ascentage Investigative Site

    Haifa, 3109601

    Recruiting

  • Ascentage Investigative Site

    Jerusalem, 91120

    Recruiting

  • Ascentage Investigative Site

    Kfar Saba, 4428164

    Recruiting

  • Ascentage Investigative Site

    Tel Aviv, 62431

    Recruiting

Other trials in Israel

Spain5 sites, 5 recruiting

  • Ascentage Investigative Site

    Barcelona, 08003

    Recruiting

  • Ascentage Investigative Site

    Barcelona, 08035

    Recruiting

  • Ascentage Investigative Site

    Palma de Mallorca, 07120

    Recruiting

  • Ascentage Investigative Site

    Santander, 39008

    Recruiting

  • Ascentage Investigative Site

    Valencia, 46015

    Recruiting

Other trials in Spain

Bulgaria4 sites, 4 recruiting

  • Ascentage Investigative Site

    Sofia, 1407

    Recruiting

  • Ascentage Investigative Site

    Sofia, 1431

    Recruiting

  • Ascentage Investigative Site

    Sofia, 1756

    Recruiting

  • Ascentage Investigative Site

    Sofia, 1797

    Recruiting

Other trials in Bulgaria

Poland4 sites, 4 recruiting

  • Ascentage Investigative Site

    Bydgoszcz, 85-048

    Recruiting

  • Ascentage Investigative Site

    Krakow, 30-727

    Recruiting

  • Ascentage Investigative Site

    Lodz, 93-513

    Recruiting

  • Ascentage Investigative Site

    Skorzewo, 60-185

    Recruiting

Other trials in Poland

Australia3 sites

  • Ascentage Investigative Site

    Gosford, 2250

    Completed

  • Ascentage Investigative Site

    Perth, 6000

    Completed

  • Ascentage Investigative Site

    Westmead, 2145

    Completed

Other trials in Australia

Germany3 sites, 3 recruiting

  • Ascentage Investigative Site

    Dresden, 01307

    Recruiting

  • Ascentage Investigative Site

    Dresden, 48149

    Recruiting

  • Ascentage Investigative Site

    München, 81377

    Recruiting

Other trials in Germany

Romania3 sites, 3 recruiting

  • Ascentage Investigative Site

    Bucharest, 022328

    Recruiting

  • Ascentage Investigative Site

    Cluj-Napoca, 400015

    Recruiting

  • Ascentage Investigative Site

    Timișoara, 300254

    Recruiting

Other trials in Romania

Slovakia2 sites, 2 recruiting

  • Ascentage Investigative Site

    Bratislava, 833 10

    Recruiting

  • Ascentage Investigative Site

    Martin, 036 59

    Recruiting

Other trials in Slovakia

Turkey (Türkiye)2 sites, 2 recruiting

  • Ascentage Investigative Site

    Kepez, 07025

    Recruiting

  • Ascentage Investigative Site

    Trabzon, 31080

    Recruiting

Other trials in Turkey (Türkiye)

Canada1 site, 1 recruiting

  • Ascentage Investigative Site

    Halifax, Nova Scotia, B3S 0H6

    Recruiting

Other trials in Canada

Czechia1 site, 1 recruiting

  • Ascentage Investigative Site

    Hradec Králové, 500 05

    Recruiting

Other trials in Czechia

About this study

Official title: A Global Multicenter, Open Label, Randomized Phase 3 Registrational Study of Lisaftoclax (APG-2575) in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (GLORA Study)

This is a global multicenter, open label, randomized, registrational phase III study to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL/SLL patients who previously treated with BTK inhibitors

Read the detailed description

Approximately 440 patients will be enrolled, the patients who meet the eligibility criteria will be randomized in a 1:1 ratio to investigational arm (lisaftoclax in combination with a BTK inhibitor) or the control arm (BTK inhibitor alone). These patients with CLL/SLL have been on BTKi monotherapy and meet all other protocol required eligibility criteria.

Conditions
CLL/SLL
Being tested
lisaftoclax +BTK inhibitor, BTK inhibitor

What participants receive

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

  • lisaftoclax +BTK inhibitorDrug

    lisaftolax + BTK inhibitor

  • BTK inhibitorDrug

    BTK inhibitor

Study groups in NCT06104566
Study groupRoleWhat they receive
Arm 1Active comparatorCombination therapy
Receives: Drug: lisaftoclax +BTK inhibitor
Arm 2Active comparatormono therapy
Receives: Drug: BTK inhibitor

What is being measured

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

  1. PFS

    To evaluate the progression-free survival (PFS) of lisaftoclax in combination with BTKi compared with BTKi monotherapy in CLL/SLL patients previously treated with BTKi as determined by independent radiological review committee (IRC) using the iwCLL guidelines

    Measured: 12 months

Secondary outcomes (1)

  1. overall survival

    To evaluate overall survival (OS) of lisaftoclax in combination with BTKi versus BTKi

    Measured: 12 months

Timeline

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

  1. First posted27 Oct 2023
  2. Study start20 Dec 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

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
Model description
1:1 ratio to investigational arm (lisaftoclax in combination with BTKi ) or the control arm (BTKi).
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06104566
Sponsor's protocol ID
APG2575CG301
Status last verified
Jun 2026
First submitted
23 Oct 2023
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lisaftoclax +BTK inhibitor and BTK inhibitor in people with CLL/SLL, run by Ascentage Pharma Group Inc. at 135 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in China, India, Italy, Russia, United States and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shanthi Marur, MD (3017925062, shanthi.marur@ascentage.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06104566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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