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.
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.
135 sites in 19 countries
China19 sites, 19 recruiting
- 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
India18 sites, 18 recruiting
- 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
Italy17 sites, 17 recruiting
- 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
Russia12 sites
- Active, not recruiting
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
United States11 sites, 11 recruiting
- 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
France11 sites, 11 recruiting
- 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
United Kingdom9 sites, 9 recruiting
- 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
Belgium5 sites, 5 recruiting
- 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
Israel5 sites, 5 recruiting
- 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
Spain5 sites, 5 recruiting
- 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
Bulgaria4 sites, 4 recruiting
- Recruiting
Ascentage Investigative Site
Sofia, 1407
- Recruiting
Ascentage Investigative Site
Sofia, 1431
- Recruiting
Ascentage Investigative Site
Sofia, 1756
- Recruiting
Ascentage Investigative Site
Sofia, 1797
Poland4 sites, 4 recruiting
- 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
Australia3 sites
- Completed
Ascentage Investigative Site
Gosford, 2250
- Completed
Ascentage Investigative Site
Perth, 6000
- Completed
Ascentage Investigative Site
Westmead, 2145
Germany3 sites, 3 recruiting
- Recruiting
Ascentage Investigative Site
Dresden, 01307
- Recruiting
Ascentage Investigative Site
Dresden, 48149
- Recruiting
Ascentage Investigative Site
München, 81377
Romania3 sites, 3 recruiting
- Recruiting
Ascentage Investigative Site
Bucharest, 022328
- Recruiting
Ascentage Investigative Site
Cluj-Napoca, 400015
- Recruiting
Ascentage Investigative Site
Timișoara, 300254
Slovakia2 sites, 2 recruiting
- Recruiting
Ascentage Investigative Site
Bratislava, 833 10
- Recruiting
Ascentage Investigative Site
Martin, 036 59
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ascentage Investigative Site
Kepez, 07025
- Recruiting
Ascentage Investigative Site
Trabzon, 31080
Canada1 site, 1 recruiting
- Recruiting
Ascentage Investigative Site
Halifax, Nova Scotia, B3S 0H6
Czechia1 site, 1 recruiting
- Recruiting
Ascentage Investigative Site
Hradec Králové, 500 05
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 group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Combination therapy Receives: Drug: lisaftoclax +BTK inhibitor |
| Arm 2 | Active comparator | mono therapy Receives: Drug: BTK inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted27 Oct 2023
- Study start20 Dec 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLL/SLLStudies of the same condition, open and under way.
- More trials run by Ascentage Pharma Group Inc.The sponsor's other registered studies.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- Ascentage Pharma Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06104566
- Acronym / sponsor ID
- APG2575CG301
- Conditions
- CLL/SLL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ascentage Pharma Group Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 ratio to investigational arm (lisaftoclax in combination with BTKi ) or the control arm (BTKi).
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: lisaftoclax +BTK inhibitorCombination therapy |
| Arm 2 | Active comparator | Drug: BTK inhibitormono therapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- Adequate renal function
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lisaftoclax +BTK inhibitorlisaftolax + BTK inhibitor | Drug | Arm 1 |
| BTK inhibitorBTK inhibitor | Drug | Arm 2 |
Primary outcome
PFS
Time frame: 12 months
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
1 secondary outcome
overall survival
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
Related trials for CLL/SLL
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
RecruitingPhase 1
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
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Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
135 sites in 19 countries: see every site and its status.
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?
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.