Global Trial in APG2575 for Patients With CLL/SLL

NCT06104566 | Recruiting Phase 3 FDA Drug

• 1 other identifier: APG2575CG301
• Study Type: interventional
• Target: 400
• Locations: 19 countries
• Sites: 135

Brief 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

Conditions

CLL/SLL

Outcome Measures

Primary Outcomes (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

  12 months

Secondary Outcomes (1)

• overall survival

  12 months

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Combination therapy

Drug: lisaftoclax +BTK inhibitor

Arm 2

ACTIVE COMPARATOR

mono therapy

Drug: BTK inhibitor

Interventions

lisaftoclax +BTK inhibitor DRUG

lisaftolax + BTK inhibitor

Arm 1

BTK inhibitor DRUG

BTK inhibitor

Arm 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

Sponsors & Collaborators

• Ascentage Pharma Group Inc.: lead

Study Sites (135)

Ascentage Investigative Site

Tuscon, Arizona, 85742, United States

RECRUITING

Ascentage Investigative Site

Anaheim, California, 92805, United States

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Ascentage Investigative Site

Jacksonville, Florida, 32224, United States

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Ascentage Investigative Site

Miami Beach, Florida, 33140, United States

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Ascentage Investigative Site

Peoria, Illinois, 61615, United States

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Ascentage Investigative Site

Boston, Massachusetts, 02215, United States

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Ascentage Investigative Site

Ann Arbor, Michigan, 48109, United States

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Ascentage Investigative Site

Greenville, North Carolina, 27834, United States

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Ascentage Investigative Site

Houston, Texas, 77030, United States

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Ascentage Investigative Site

Kingswood, Texas, 77339, United States

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Ascentage Investigative Site

Richmond, Virginia, 23298, United States

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Ascentage Investigative Site

Gosford, 2250, Australia

COMPLETED

Ascentage Investigative Site

Perth, 6000, Australia

COMPLETED

Ascentage Investigative Site

Westmead, 2145, Australia

COMPLETED

Ascentage Investigative Site

Ghent, 9000, Belgium

RECRUITING

Ascentage Investigative Site

La Louvière, 7100, Belgium

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Ascentage Investigative Site

Leuven, 3000, Belgium

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Ascentage Investigative Site

Ottignies, 1349, Belgium

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Ascentage Investigative Site

Roeselare, 8800, Belgium

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Ascentage Investigative Site

Sofia, 1407, Bulgaria

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Ascentage Investigative Site

Sofia, 1431, Bulgaria

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Ascentage Investigative Site

Sofia, 1756, Bulgaria

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Ascentage Investigative Site

Sofia, 1797, Bulgaria

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Ascentage Investigative Site

Halifax, Nova Scotia, B3S 0H6, Canada

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Ascentage Investigative Site

Hefei, Anhui, 230031, China

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Ascentage Investigative Site

Beijing, Beijing Municipality, 100005, China

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Ascentage Investigative Site

Fuzhou, Fujian, 350001, China

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Ascentage Investigative Site

Foshan, Guangdong, 528000, China

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Ascentage Investigative Site

Guangzhou, Guangdong, 510050, China

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Ascentage Investigative Site

Nanning, Guangxie, 530022, China

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Ascentage Investigative Site

Zhengzhou, Henan, 450003, China

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Ascentage Investigative Site

Wuhan, Hubei, 430022, China

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Ascentage Investigative Site

Chenzhou, Hunan, 423000, China

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Ascentage Investigative Site

Nanjing, Jiangsu, 210029, China

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Ascentage Investigative Site

Suzhou, Jiangsu, 215026, China

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Ascentage Investigative Site

Wuxi, Jiangsu, 214023, China

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Ascentage Investigative Site

Nanchang, Jiangxi, 330008, China

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Ascentage Investigative Site

Xi'an, Shaanxi, 710061, China

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Ascentage Investigative Site

Binzhou, Shandong, 256600, China

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Ascentage Investigative Site

Taiyuan, Shanxi, 030013, China

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Ascentage Investigative Site

Luzhou, Sichuan, 646099, China

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Ascentage Investigative Site

Yibin, Sichuan, 644099, China

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Ascentage Investigative Site

Guangzhou, 510090, China

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Ascentage Investigative Site

Hradec Králové, 500 05, Czechia

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Ascentage Investigative Site

Clermont-Ferrand, 63000, France

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Ascentage Investigative Site

Le Mans, 72037, France

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Ascentage Investigative Site

Lyon, 69373, France

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Ascentage Investigative Site

Nantes, 44000, France

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Ascentage Investigative Site

Nantes, 44277, France

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Ascentage Investigative Site

Nîmes, 30029, France

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Ascentage Investigative Site

Orléans, 45100, France

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Ascentage Investigative Site

Poitiers, 86000, France

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Ascentage Investigative Site

Pontoise, 95300, France

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Ascentage Investigative Site

Strasbourg, 67091, France

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Ascentage Investigative Site

Tours, 37000, France

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Ascentage Investigative Site

Dresden, 01307, Germany

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Ascentage Investigative Site

Dresden, 48149, Germany

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Ascentage Investigative Site

München, 81377, Germany

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Ascentage Investigative Site

Gandhinagar, Gujarat, 382428, India

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Ascentage Investigative Site

Gurugramam, Haryana, 122001, India

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Ascentage Investigative Site

Gurugramam, Haryana, 122002, India

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Ascentage Investigative Site

Jhajjar, Haryana, 124105, India

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Ascentage Investigative Site

Bangalore, Karnataka, 560027, India

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Ascentage Investigative Site

Mysuru, Karnataka, 570023, India

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Ascentage Investigative Site

Navi Mumbai, Maharashtra, 400614, India

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Ascentage Investigative Site

Pune, Maharashtra, 411001, India

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Ascentage Investigative Site

Delhi, National Capital Territory of Delhi, 110085, India

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Ascentage Investigative Site

New Delhi, New Delhi, 110017, India

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Ascentage Investigative Site

New Delhi, New Delhi, 110029, India

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Ascentage Investigative Site

New Delhi, New Delhi, 110076, India

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Ascentage Investigative Site

New Delhi, New, 110017, India

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Ascentage Investigative Site

Madurai, Tamil Nadu, 625020, India

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Ascentage Investigative Site

Hyderabad, Telangana, 500033, India

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Ascentage Investigative Site

Kolkata, West Bengal, 700014, India

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Ascentage Investigative Site

Kolkata, West Bengal, 700054, India

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Ascentage Investigative Site

Puducherry, 605006, India

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Ascentage Investigative Site

Haifa, 31048, Israel

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Ascentage Investigative Site

Haifa, 3109601, Israel

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Ascentage Investigative Site

Jerusalem, 91120, Israel

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Ascentage Investigative Site

Kfar Saba, 4428164, Israel

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Ascentage Investigative Site

Tel Aviv, 62431, Israel

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Ascentage Investigative Site

Aviano, 33081, Italy

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Ascentage Investigative Site

Brescia, 25123, Italy

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Ascentage Investigative Site

Cona, 44124, Italy

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Ascentage Investigative Site

Genova, 16132, Italy

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Ascentage Investigative Site

Lecce, 73100, Italy

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Ascentage Investigative Site

Meldola, 47014, Italy

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Ascentage Investigative Site

Milan, 20141, Italy

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Ascentage Investigative Site

Milan, 20132, Italy

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Ascentage Investigative Site

Padova, 35122, Italy

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Ascentage Investigative Site

Piacenza, 29121, Italy

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Ascentage Investigative Site

Ravenna, 48121, Italy

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Ascentage Investigative Site

Reggio Emilia, 42123, Italy

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Ascentage Investigative Site

Rimini, 47923, Italy

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Ascentage Investigative Site

Roma, 00128, Italy

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Ascentage Investigative Site

Roma, 00168, Italy

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Ascentage Investigative Site

Torino, 10126, Italy

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Ascentage Investigative Site

Udine, 33100, Italy

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Ascentage Investigative Site

Bydgoszcz, 85-048, Poland

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Ascentage Investigative Site

Krakow, 30-727, Poland

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Ascentage Investigative Site

Lodz, 93-513, Poland

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Ascentage Investigative Site

Skorzewo, 60-185, Poland

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Ascentage Investigative Site

Bucharest, 022328, Romania

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Ascentage Investigative Site

Cluj-Napoca, 400015, Romania

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Ascentage Investigative Site

Timișoara, 300254, Romania

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Ascentage Investigative Site

Saint Petersburg, Kaluga Oblast, 248008, Russia

ACTIVE NOT RECRUITING

Ascentage Investigative Site

Kirov, Kirov Oblast, 610027, Russia

ACTIVE NOT RECRUITING

Ascentage Investigative Site

Kaluga, 246007, Russia

ACTIVE NOT RECRUITING

Ascentage Investigative Site

Kazan', 420029, Russia

ACTIVE NOT RECRUITING

Ascentage Investigative Site

Moscow, 115522, Russia

ACTIVE NOT RECRUITING

Ascentage Investigative Site

Moscow, 123182, Russia

ACTIVE NOT RECRUITING

Ascentage Investigative Site

Moscow, 125284, Russia

ACTIVE NOT RECRUITING

Ascentage Investigative Site

Petrozavodsk, 185019, Russia

ACTIVE NOT RECRUITING

Ascentage Investigative Site

Saint Petersburg, 197022, Russia

ACTIVE NOT RECRUITING

Ascentage Investigative Site

Saint Petersburg, 197341, Russia

ACTIVE NOT RECRUITING

Ascentage Investigative Site

Sochi, 354057, Russia

ACTIVE NOT RECRUITING

Ascentage Investigative Site

Syktyvkar, 167904, Russia

ACTIVE NOT RECRUITING

Ascentage Investigative Site

Bratislava, 833 10, Slovakia

RECRUITING

Ascentage Investigative Site

Martin, 036 59, Slovakia

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Ascentage Investigative Site

Barcelona, 08003, Spain

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Ascentage Investigative Site

Barcelona, 08035, Spain

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Ascentage Investigative Site

Palma de Mallorca, 07120, Spain

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Ascentage Investigative Site

Santander, 39008, Spain

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Ascentage Investigative Site

Valencia, 46015, Spain

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Ascentage Investigative Site

Kepez, 07025, Turkey (Türkiye)

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Ascentage Investigative Site

Trabzon, 31080, Turkey (Türkiye)

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Ascentage Investigative Site

Birmingham, B15 2GW, United Kingdom

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Ascentage Investigative Site

Bournemouth, BH7 7DW, United Kingdom

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Ascentage Investigative Site

Liverpool, L7 8YA, United Kingdom

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Ascentage Investigative Site

London, SW3 6JJ, United Kingdom

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Ascentage Investigative Site

Manchester, M20 4BX, United Kingdom

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Ascentage Investigative Site

Stoke-on-Trent, ST4 6QG, United Kingdom

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Ascentage Investigative Site

Swansea, SA2 8QA, United Kingdom

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Ascentage Investigative Site

West Bromwich, B71 4HJ, United Kingdom

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Ascentage Investigative Site

Wolverhampton, WV10 0QP, United Kingdom

RECRUITING

Central Study Contacts

Shanthi Marur, MD

CONTACT

3017925062; shanthi.marur@ascentage.com

Yifan Zhai, MD

CONTACT

301-549-6188; yzhai@ascentage.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 ratio to investigational arm (lisaftoclax in combination with BTKi ) or the control arm (BTKi).

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: December 20, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

BU (4); FR (11); IN (18); CN (19); AU (3); RO (3); CA (1); ES (5); SL (2); BE (5); CZ (1); TU (2); IL (5); PL (4); IT (17); DE (3); GB (9); RU (12); US (11)