NCT06104566RecruitingPhase 3
Global Trial in APG2575 for Patients With CLL/SLL
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)
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 23 Oct 2023
- Start date
- 20 Dec 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Ascentage Pharma Group Inc.
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT06104566
- EU CT number
- 2023-508005-24-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From 20 Dec 2023 to the primary completion date, 31 Dec 2026
- 143 sites in 20 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
- Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (143)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Gosford | Australia | Completed |
| - Coordinator of this site? Confirm its status | Perth | Australia | Completed |
| - Coordinator of this site? Confirm its status | Westmead | Australia | Completed |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Chu Helora Coordinator of this site? Confirm its status | La Louvière | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Clinique Saint Pierre Coordinator of this site? Confirm its status | Ottignies-Louvain-la-Neuve | Belgium | Recruiting |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Yvoir | Belgium | Recruiting |
| Dr. Pencho Georgiev Ambulatory For Individual Practice For Medical Aid For Clinical Hematology EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| Medical Center Pulmovision Ltd. Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Specialized Hospital For Active Treatment Of Hematological Diseases EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Acibadem City Clinic Tokuda University Hospital EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Umbal - Prof. D-R Stoyan Kirkovich AD Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Recruiting |
| MBAL Sveta Marina EAD Coordinator of this site? Confirm its status | Varna | Bulgaria | Recruiting |
| - Coordinator of this site? Confirm its status | Halifax | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| - Coordinator of this site? Confirm its status | Binzhou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Chenzhou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Foshan | China | Recruiting |
| - Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| - Coordinator of this site? Confirm its status | Luzhou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| - Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| - Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| - Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| - Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| - Coordinator of this site? Confirm its status | Wuxi | China | Recruiting |
| - Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| - Coordinator of this site? Confirm its status | Yibin | China | Recruiting |
| - Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Recruiting |
| Gemeinschaftspraxis Haematologie Onkologie Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Onkozentrum Dresden Freiberg Meissen Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Klinische Forschung Karlsruhe GmbH Coordinator of this site? Confirm its status | Karlsruhe | Germany | Recruiting |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Sana Klinikum Offenbach GmbH Coordinator of this site? Confirm its status | Offenbach Am Main | Germany | Recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Recruiting |
| Hospital Son Llatzer Coordinator of this site? Confirm its status | Palma | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Hospital Arnau de Vilanova de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Centre Hospitalier Le Mans Coordinator of this site? Confirm its status | Le Mans Cedex 9 | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| L'Hopital Prive Du Confluent Coordinator of this site? Confirm its status | Nantes Cedex 2 | France | Recruiting |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice Cedex 2 | France | Recruiting |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Recruiting |
| Centre Hospitalier Universitaire D Orleans Coordinator of this site? Confirm its status | Orleans Cedex 2 | France | Recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Hôpital NOVO Coordinator of this site? Confirm its status | Pontoise | France | Recruiting |
| Groupe Hospitalier Saint Vincent Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Tours Cedex 9 | France | Recruiting |
| - Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Bournemouth | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Swansea | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | West Bromwich | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Wolverhampton | United Kingdom | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Recruiting |
| Szabolcs Szatmár Bereg Vármegyei Oktatókórház Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Recruiting |
| - Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Kfar Saba | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Bangalore | India | Recruiting |
| - Coordinator of this site? Confirm its status | Delhi | India | Recruiting |
| - Coordinator of this site? Confirm its status | Gandhinagar | India | Recruiting |
| - Coordinator of this site? Confirm its status | Gurugramam | India | Recruiting |
| - Coordinator of this site? Confirm its status | Hyderabad | India | Recruiting |
| - Coordinator of this site? Confirm its status | Jhajjar | India | Recruiting |
| - Coordinator of this site? Confirm its status | Kolkata | India | Recruiting |
| - Coordinator of this site? Confirm its status | Madurai | India | Recruiting |
| - Coordinator of this site? Confirm its status | Mysuru | India | Recruiting |
| - Coordinator of this site? Confirm its status | Navi Mumbai | India | Recruiting |
| - Coordinator of this site? Confirm its status | New Delhi | India | Recruiting |
| - Coordinator of this site? Confirm its status | Puducherry | India | Recruiting |
| - Coordinator of this site? Confirm its status | Pune | India | Recruiting |
| Centro di Riferimento Oncologico di Aviano Coordinator of this site? Confirm its status | Aviano | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| University Hospital Of Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Ospedale Vito Fazzi Lecce Coordinator of this site? Confirm its status | Lecce | Italy | Recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Recruiting |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedale Universita Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Hospital Santa Maria Della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Recruiting |
| Azienda Unita Sanitaria Locale Di Piacenza Coordinator of this site? Confirm its status | Piacenza | Italy | Recruiting |
| Azienda Unità Sanitaria Locale della Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Recruiting |
| Azienda USL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Recruiting |
| Azienda Unita Sanitaria Locale Della Romagna Coordinator of this site? Confirm its status | Rimini | Italy | Recruiting |
| Università Campus Bio-Medico di Roma Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale Dei Sette Laghi Coordinator of this site? Confirm its status | Varese | Italy | Recruiting |
| In- Vivo Sp. z o. o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Aidport sp z o.o. Coordinator of this site? Confirm its status | Skorzewo | Poland | Recruiting |
| Institutul Clinic Fundeni Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Spitalul Clinic Municipal De Urgenta Timisoara Coordinator of this site? Confirm its status | Timisoara | Romania | Recruiting |
| - Coordinator of this site? Confirm its status | Kaluga | Russia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Kazan' | Russia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Kirov | Russia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Moscow | Russia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Petrozavodsk | Russia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Sochi | Russia | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Syktyvkar | Russia | Active, not recruiting |
| National Oncology Institute Coordinator of this site? Confirm its status | Bratislava | Slovakia | Recruiting |
| Univerzitna nemocnica Martin Coordinator of this site? Confirm its status | Martin | Slovakia | Recruiting |
| - Coordinator of this site? Confirm its status | Anaheim | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Kingswood | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Miami Beach | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Tuscon | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Kepez | Turkey (Türkiye) | Recruiting |
| - Coordinator of this site? Confirm its status | Trabzon | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.