Global Trial in APG2575 for Patients With CLL/SLL

June 16, 2026 updated by: Ascentage Pharma Group Inc.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Gosford, Australia, 2250
        • Completed
        • Ascentage Investigative Site
      • Perth, Australia, 6000
        • Completed
        • Ascentage Investigative Site
      • Westmead, Australia, 2145
        • Completed
        • Ascentage Investigative Site
  • Belgium
      • Ghent, Belgium, 9000
        • Recruiting
        • Ascentage Investigative Site
      • La Louvière, Belgium, 7100
        • Recruiting
        • Ascentage Investigative Site
      • Leuven, Belgium, 3000
        • Recruiting
        • Ascentage Investigative Site
      • Ottignies, Belgium, 1349
        • Recruiting
        • Ascentage Investigative Site
      • Roeselare, Belgium, 8800
        • Recruiting
        • Ascentage Investigative Site
  • Bulgaria
      • Sofia, Bulgaria, 1407
        • Recruiting
        • Ascentage Investigative Site
      • Sofia, Bulgaria, 1431
        • Recruiting
        • Ascentage Investigative Site
      • Sofia, Bulgaria, 1756
        • Recruiting
        • Ascentage Investigative Site
      • Sofia, Bulgaria, 1797
        • Recruiting
        • Ascentage Investigative Site
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3S 0H6
        • Recruiting
        • Ascentage Investigative Site
  • China
      • Guangzhou, China, 510090
        • Recruiting
        • Ascentage Investigative Site
    • Anhui
      • Hefei, Anhui, China, 230031
        • Recruiting
        • Ascentage Investigative Site
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100005
        • Recruiting
        • Ascentage Investigative Site
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Ascentage Investigative Site
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Recruiting
        • Ascentage Investigative Site
      • Guangzhou, Guangdong, China, 510050
        • Recruiting
        • Ascentage Investigative Site
    • Guangxie
      • Nanning, Guangxie, China, 530022
        • Recruiting
        • Ascentage Investigative Site
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Ascentage Investigative Site
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Ascentage Investigative Site
    • Hunan
      • Chenzhou, Hunan, China, 423000
        • Recruiting
        • Ascentage Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Ascentage Investigative Site
      • Suzhou, Jiangsu, China, 215026
        • Recruiting
        • Ascentage Investigative Site
      • Wuxi, Jiangsu, China, 214023
        • Recruiting
        • Ascentage Investigative Site
    • Jiangxi
      • Nanchang, Jiangxi, China, 330008
        • Recruiting
        • Ascentage Investigative Site
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • Ascentage Investigative Site
    • Shandong
      • Binzhou, Shandong, China, 256600
        • Recruiting
        • Ascentage Investigative Site
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Recruiting
        • Ascentage Investigative Site
    • Sichuan
      • Luzhou, Sichuan, China, 646099
        • Recruiting
        • Ascentage Investigative Site
      • Yibin, Sichuan, China, 644099
        • Recruiting
        • Ascentage Investigative Site
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Recruiting
        • Ascentage Investigative Site
  • France
      • Clermont-Ferrand, France, 63000
        • Recruiting
        • Ascentage Investigative Site
      • Le Mans, France, 72037
        • Recruiting
        • Ascentage Investigative Site
      • Lyon, France, 69373
        • Recruiting
        • Ascentage Investigative Site
      • Nantes, France, 44000
        • Recruiting
        • Ascentage Investigative Site
      • Nantes, France, 44277
        • Recruiting
        • Ascentage Investigative Site
      • Nîmes, France, 30029
        • Recruiting
        • Ascentage Investigative Site
      • Orléans, France, 45100
        • Recruiting
        • Ascentage Investigative Site
      • Poitiers, France, 86000
        • Recruiting
        • Ascentage Investigative Site
      • Pontoise, France, 95300
        • Recruiting
        • Ascentage Investigative Site
      • Strasbourg, France, 67091
        • Recruiting
        • Ascentage Investigative Site
      • Tours, France, 37000
        • Recruiting
        • Ascentage Investigative Site
  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • Ascentage Investigative Site
      • Dresden, Germany, 48149
        • Recruiting
        • Ascentage Investigative Site
      • München, Germany, 81377
        • Recruiting
        • Ascentage Investigative Site
  • India
      • Puducherry, India, 605006
        • Recruiting
        • Ascentage Investigative Site
    • Gujarat
      • Gandhinagar, Gujarat, India, 382428
        • Recruiting
        • Ascentage Investigative Site
    • Haryana
      • Gurugramam, Haryana, India, 122001
        • Recruiting
        • Ascentage Investigative Site
      • Gurugramam, Haryana, India, 122002
        • Recruiting
        • Ascentage Investigative Site
      • Jhajjar, Haryana, India, 124105
        • Recruiting
        • Ascentage Investigative Site
    • Karnataka
      • Bangalore, Karnataka, India, 560027
        • Recruiting
        • Ascentage Investigative Site
      • Mysuru, Karnataka, India, 570023
        • Recruiting
        • Ascentage Investigative Site
    • Maharashtra
      • Navi Mumbai, Maharashtra, India, 400614
        • Recruiting
        • Ascentage Investigative Site
      • Pune, Maharashtra, India, 411001
        • Recruiting
        • Ascentage Investigative Site
    • National Capital Territory of Delhi
      • Delhi, National Capital Territory of Delhi, India, 110085
        • Recruiting
        • Ascentage Investigative Site
    • New
      • New Delhi, New, India, 110017
        • Recruiting
        • Ascentage Investigative Site
    • New Delhi
      • New Delhi, New Delhi, India, 110017
        • Recruiting
        • Ascentage Investigative Site
      • New Delhi, New Delhi, India, 110029
        • Recruiting
        • Ascentage Investigative Site
      • New Delhi, New Delhi, India, 110076
        • Recruiting
        • Ascentage Investigative Site
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625020
        • Recruiting
        • Ascentage Investigative Site
    • Telangana
      • Hyderabad, Telangana, India, 500033
        • Recruiting
        • Ascentage Investigative Site
    • West Bengal
      • Kolkata, West Bengal, India, 700014
        • Recruiting
        • Ascentage Investigative Site
      • Kolkata, West Bengal, India, 700054
        • Recruiting
        • Ascentage Investigative Site
  • Israel
      • Haifa, Israel, 31048
        • Recruiting
        • Ascentage Investigative Site
      • Haifa, Israel, 3109601
        • Recruiting
        • Ascentage Investigative Site
      • Jerusalem, Israel, 91120
        • Recruiting
        • Ascentage Investigative Site
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Ascentage Investigative Site
      • Tel Aviv, Israel, 62431
        • Recruiting
        • Ascentage Investigative Site
  • Italy
      • Aviano, Italy, 33081
        • Recruiting
        • Ascentage Investigative Site
      • Brescia, Italy, 25123
        • Recruiting
        • Ascentage Investigative Site
      • Cona, Italy, 44124
        • Recruiting
        • Ascentage Investigative Site
      • Genova, Italy, 16132
        • Recruiting
        • Ascentage Investigative Site
      • Lecce, Italy, 73100
        • Recruiting
        • Ascentage Investigative Site
      • Meldola, Italy, 47014
        • Recruiting
        • Ascentage Investigative Site
      • Milan, Italy, 20141
        • Recruiting
        • Ascentage Investigative Site
      • Milan, Italy, 20132
        • Recruiting
        • Ascentage Investigative Site
      • Padova, Italy, 35122
        • Recruiting
        • Ascentage Investigative Site
      • Piacenza, Italy, 29121
        • Recruiting
        • Ascentage Investigative Site
      • Ravenna, Italy, 48121
        • Recruiting
        • Ascentage Investigative Site
      • Reggio Emilia, Italy, 42123
        • Recruiting
        • Ascentage Investigative Site
      • Rimini, Italy, 47923
        • Recruiting
        • Ascentage Investigative Site
      • Roma, Italy, 00128
        • Recruiting
        • Ascentage Investigative Site
      • Roma, Italy, 00168
        • Recruiting
        • Ascentage Investigative Site
      • Torino, Italy, 10126
        • Recruiting
        • Ascentage Investigative Site
      • Udine, Italy, 33100
        • Recruiting
        • Ascentage Investigative Site
  • Poland
      • Bydgoszcz, Poland, 85-048
        • Recruiting
        • Ascentage Investigative Site
      • Krakow, Poland, 30-727
        • Recruiting
        • Ascentage Investigative Site
      • Lodz, Poland, 93-513
        • Recruiting
        • Ascentage Investigative Site
      • Skorzewo, Poland, 60-185
        • Recruiting
        • Ascentage Investigative Site
  • Romania
      • Bucharest, Romania, 022328
        • Recruiting
        • Ascentage Investigative Site
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • Ascentage Investigative Site
      • Timișoara, Romania, 300254
        • Recruiting
        • Ascentage Investigative Site
  • Russia
      • Kaluga, Russia, 246007
        • Active, not recruiting
        • Ascentage Investigative Site
      • Kazan', Russia, 420029
        • Active, not recruiting
        • Ascentage Investigative Site
      • Moscow, Russia, 115522
        • Active, not recruiting
        • Ascentage Investigative Site
      • Moscow, Russia, 123182
        • Active, not recruiting
        • Ascentage Investigative Site
      • Moscow, Russia, 125284
        • Active, not recruiting
        • Ascentage Investigative Site
      • Petrozavodsk, Russia, 185019
        • Active, not recruiting
        • Ascentage Investigative Site
      • Saint Petersburg, Russia, 197022
        • Active, not recruiting
        • Ascentage Investigative Site
      • Saint Petersburg, Russia, 197341
        • Active, not recruiting
        • Ascentage Investigative Site
      • Sochi, Russia, 354057
        • Active, not recruiting
        • Ascentage Investigative Site
      • Syktyvkar, Russia, 167904
        • Active, not recruiting
        • Ascentage Investigative Site
    • Kaluga Oblast
      • Saint Petersburg, Kaluga Oblast, Russia, 248008
        • Active, not recruiting
        • Ascentage Investigative Site
    • Kirov Oblast
      • Kirov, Kirov Oblast, Russia, 610027
        • Active, not recruiting
        • Ascentage Investigative Site
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • Recruiting
        • Ascentage Investigative Site
      • Martin, Slovakia, 036 59
        • Recruiting
        • Ascentage Investigative Site
  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Ascentage Investigative Site
      • Barcelona, Spain, 08035
        • Recruiting
        • Ascentage Investigative Site
      • Palma de Mallorca, Spain, 07120
        • Recruiting
        • Ascentage Investigative Site
      • Santander, Spain, 39008
        • Recruiting
        • Ascentage Investigative Site
      • Valencia, Spain, 46015
        • Recruiting
        • Ascentage Investigative Site
  • Turkey (Türkiye)
      • Kepez, Turkey (Türkiye), 07025
        • Recruiting
        • Ascentage Investigative Site
      • Trabzon, Turkey (Türkiye), 31080
        • Recruiting
        • Ascentage Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • Recruiting
        • Ascentage Investigative Site
      • Bournemouth, United Kingdom, BH7 7DW
        • Recruiting
        • Ascentage Investigative Site
      • Liverpool, United Kingdom, L7 8YA
        • Recruiting
        • Ascentage Investigative Site
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • Ascentage Investigative Site
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • Ascentage Investigative Site
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Recruiting
        • Ascentage Investigative Site
      • Swansea, United Kingdom, SA2 8QA
        • Recruiting
        • Ascentage Investigative Site
      • West Bromwich, United Kingdom, B71 4HJ
        • Recruiting
        • Ascentage Investigative Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Recruiting
        • Ascentage Investigative Site
  • United States
    • Arizona
      • Tuscon, Arizona, United States, 85742
        • Recruiting
        • Ascentage Investigative Site
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Ascentage Investigative Site
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Ascentage Investigative Site
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Ascentage Investigative Site
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Ascentage Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Ascentage Investigative Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • Ascentage Investigative Site
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • Ascentage Investigative Site
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Ascentage Investigative Site
        • Principal Investigator:
          • Nitin Jain, MD
      • Kingswood, Texas, United States, 77339
        • Recruiting
        • Ascentage Investigative Site
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Ascentage Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. 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
  3. ECOG Performance Status grade 0-2

  4. 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
    • Total hemoglobin ≥ 9 g/dL,

  5. 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.

  6. 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.
  7. Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1
Combination therapy
Drug: lisaftoclax +BTK inhibitor
lisaftolax + BTK inhibitor
Active Comparator: Arm 2
mono therapy
Drug: BTK inhibitor
BTK inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 12 months
To evaluate overall survival (OS) of lisaftoclax in combination with BTKi versus BTKi
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascentage Pharma Group Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • APG2575CG301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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