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NCT06104566PHASE3Recruiting

Global Trial in APG2575 for Patients With CLL/SLL

Ascentage Pharma Group Inc.

Start Date

12/20/2023

Completion Date

10/31/2027

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

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.

Eligibility Criteria

Age Range: 18 years to 99 years

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

Interventions

DRUG

lisaftoclax +BTK inhibitor

DRUG

BTK inhibitor

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Conditions

CLL/SLL

Locations

Ascentage Investigative Site

Tuscon, Arizona 85742

United States

Ascentage Investigative Site

Anaheim, California 92805

United States

Ascentage Investigative Site

Jacksonville, Florida 32224

United States

Ascentage Investigative Site

Miami Beach, Florida 33140

United States

Ascentage Investigative Site

Peoria, Illinois 61615

United States

Ascentage Investigative Site

Boston, Massachusetts 02215

United States

Ascentage Investigative Site

Ann Arbor, Michigan 48109

United States

Ascentage Investigative Site

Greenville, North Carolina 27834

United States

Ascentage Investigative Site

Houston, Texas 77030

United States

Ascentage Investigative Site

Kingswood, Texas 77339

United States

Ascentage Investigative Site

Richmond, Virginia 23298

United States

Ascentage Investigative Site

Gosford, 2250

Australia

Ascentage Investigative Site

Perth, 6000

Australia

Ascentage Investigative Site

Westmead, 2145

Australia

Ascentage Investigative Site

Ghent, 9000

Belgium

Ascentage Investigative Site

La Louvière, 7100

Belgium

Ascentage Investigative Site

Leuven, 3000

Belgium

Ascentage Investigative Site

Ottignies, 1349

Belgium

Ascentage Investigative Site

Roeselare, 8800

Belgium

Ascentage Investigative Site

Sofia, 1407

Bulgaria

Ascentage Investigative Site

Sofia, 1431

Bulgaria

Ascentage Investigative Site

Sofia, 1756

Bulgaria

Ascentage Investigative Site

Sofia, 1797

Bulgaria

Ascentage Investigative Site

Halifax, Nova Scotia B3S 0H6

Canada

Ascentage Investigative Site

Hefei, Anhui 230031

China

Ascentage Investigative Site

Beijing, Beijing Municipality 100005

China

Ascentage Investigative Site

Fuzhou, Fujian 350001

China

Ascentage Investigative Site

Foshan, Guangdong 528000

China

Ascentage Investigative Site

Guangzhou, Guangdong 510050

China

Ascentage Investigative Site

Nanning, Guangxie 530022

China

Ascentage Investigative Site

Zhengzhou, Henan 450003

China

Ascentage Investigative Site

Wuhan, Hubei 430022

China

Ascentage Investigative Site

Chenzhou, Hunan 423000

China

Ascentage Investigative Site

Nanjing, Jiangsu 210029

China

Ascentage Investigative Site

Suzhou, Jiangsu 215026

China

Ascentage Investigative Site

Wuxi, Jiangsu 214023

China

Ascentage Investigative Site

Nanchang, Jiangxi 330008

China

Ascentage Investigative Site

Xi'an, Shaanxi 710061

China

Ascentage Investigative Site

Binzhou, Shandong 256600

China

Ascentage Investigative Site

Taiyuan, Shanxi 030013

China

Ascentage Investigative Site

Luzhou, Sichuan 646099

China

Ascentage Investigative Site

Yibin, Sichuan 644099

China

Ascentage Investigative Site

Guangzhou, 510090

China

Ascentage Investigative Site

Hradec Králové, 500 05

Czechia

Ascentage Investigative Site

Clermont-Ferrand, 63000

France

Ascentage Investigative Site

Le Mans, 72037

France

Ascentage Investigative Site

Lyon, 69373

France

Ascentage Investigative Site

Nantes, 44000

France

Ascentage Investigative Site

Nantes, 44277

France

Ascentage Investigative Site

Nîmes, 30029

France

Ascentage Investigative Site

Orléans, 45100

France

Ascentage Investigative Site

Poitiers, 86000

France

Ascentage Investigative Site

Pontoise, 95300

France

Ascentage Investigative Site

Strasbourg, 67091

France

Ascentage Investigative Site

Tours, 37000

France

Ascentage Investigative Site

Dresden, 01307

Germany

Ascentage Investigative Site

Dresden, 48149

Germany

Ascentage Investigative Site

München, 81377

Germany

Ascentage Investigative Site

Gandhinagar, Gujarat 382428

India

Ascentage Investigative Site

Gurugramam, Haryana 122001

India

Ascentage Investigative Site

Gurugramam, Haryana 122002

India

Ascentage Investigative Site

Jhajjar, Haryana 124105

India

Ascentage Investigative Site

Bangalore, Karnataka 560027

India

Ascentage Investigative Site

Mysuru, Karnataka 570023

India

Ascentage Investigative Site

Navi Mumbai, Maharashtra 400614

India

Ascentage Investigative Site

Pune, Maharashtra 411001

India

Ascentage Investigative Site

Delhi, National Capital Territory of Delhi 110085

India

Ascentage Investigative Site

New Delhi, New Delhi 110017

India

Ascentage Investigative Site

New Delhi, New Delhi 110029

India

Ascentage Investigative Site

New Delhi, New Delhi 110076

India

Ascentage Investigative Site

New Delhi, New 110017

India

Ascentage Investigative Site

Madurai, Tamil Nadu 625020

India

Ascentage Investigative Site

Hyderabad, Telangana 500033

India

Ascentage Investigative Site

Kolkata, West Bengal 700014

India

Ascentage Investigative Site

Kolkata, West Bengal 700054

India

Ascentage Investigative Site

Puducherry, 605006

India

Ascentage Investigative Site

Haifa, 31048

Israel

Ascentage Investigative Site

Haifa, 3109601

Israel

Ascentage Investigative Site

Jerusalem, 91120

Israel

Ascentage Investigative Site

Kfar Saba, 4428164

Israel

Ascentage Investigative Site

Tel Aviv, 62431

Israel

Ascentage Investigative Site

Aviano, 33081

Italy

Ascentage Investigative Site

Brescia, 25123

Italy

Ascentage Investigative Site

Cona, 44124

Italy

Ascentage Investigative Site

Genova, 16132

Italy

Ascentage Investigative Site

Lecce, 73100

Italy

Ascentage Investigative Site

Meldola, 47014

Italy

Ascentage Investigative Site

Milan, 20141

Italy

Ascentage Investigative Site

Milan, 20132

Italy

Ascentage Investigative Site

Padova, 35122

Italy

Ascentage Investigative Site

Piacenza, 29121

Italy

Ascentage Investigative Site

Ravenna, 48121

Italy

Ascentage Investigative Site

Reggio Emilia, 42123

Italy

Ascentage Investigative Site

Rimini, 47923

Italy

Ascentage Investigative Site

Roma, 00128

Italy

Ascentage Investigative Site

Roma, 00168

Italy

Ascentage Investigative Site

Torino, 10126

Italy

Ascentage Investigative Site

Udine, 33100

Italy

Ascentage Investigative Site

Bydgoszcz, 85-048

Poland

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Krakow, 30-727

Poland

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Lodz, 93-513

Poland

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Skorzewo, 60-185

Poland

Ascentage Investigative Site

Bucharest, 022328

Romania

Ascentage Investigative Site

Cluj-Napoca, 400015

Romania

Ascentage Investigative Site

Timișoara, 300254

Romania

Ascentage Investigative Site

Saint Petersburg, Kaluga Oblast 248008

Russia

Ascentage Investigative Site

Kirov, Kirov Oblast 610027

Russia

Ascentage Investigative Site

Kaluga, 246007

Russia

Ascentage Investigative Site

Kazan', 420029

Russia

Ascentage Investigative Site

Moscow, 115522

Russia

Ascentage Investigative Site

Moscow, 123182

Russia

Ascentage Investigative Site

Moscow, 125284

Russia

Ascentage Investigative Site

Petrozavodsk, 185019

Russia

Ascentage Investigative Site

Saint Petersburg, 197022

Russia

Ascentage Investigative Site

Saint Petersburg, 197341

Russia

Ascentage Investigative Site

Sochi, 354057

Russia

Ascentage Investigative Site

Syktyvkar, 167904

Russia

Ascentage Investigative Site

Bratislava, 833 10

Slovakia

Ascentage Investigative Site

Martin, 036 59

Slovakia

Ascentage Investigative Site

Barcelona, 08003

Spain

Ascentage Investigative Site

Barcelona, 08035

Spain

Ascentage Investigative Site

Palma de Mallorca, 07120

Spain

Ascentage Investigative Site

Santander, 39008

Spain

Ascentage Investigative Site

Valencia, 46015

Spain

Ascentage Investigative Site

Kepez, 07025

Turkey (Türkiye)

Ascentage Investigative Site

Trabzon, 31080

Turkey (Türkiye)

Ascentage Investigative Site

Birmingham, B15 2GW

United Kingdom

Ascentage Investigative Site

Bournemouth, BH7 7DW

United Kingdom

Ascentage Investigative Site

Liverpool, L7 8YA

United Kingdom

Ascentage Investigative Site

London, SW3 6JJ

United Kingdom

Ascentage Investigative Site

Manchester, M20 4BX

United Kingdom

Ascentage Investigative Site

Stoke-on-Trent, ST4 6QG

United Kingdom

Ascentage Investigative Site

Swansea, SA2 8QA

United Kingdom

Ascentage Investigative Site

West Bromwich, B71 4HJ

United Kingdom

Ascentage Investigative Site

Wolverhampton, WV10 0QP

United Kingdom