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Taking peoplePhase 3

Tests lisaftoclax with a BTK inhibitor in adults with previously treated CLL or SLL

Tests lisaftoclax with a BTK inhibitor in adults with CLL or SLL.

Key facts

Who runs it
Ascentage Pharma Group Inc.
Where
Kaluga, Kazan', Kirov, Moscow, Petrozavodsk, Saint Petersburg, Sochi, and Syktyvkar, RussiaSee the 8 sitesAlso in 19 other countries, 135 sites
Registry title
Global Trial in APG2575 for Patients With CLL/SLL
Status
Recruiting
Phase
Phase 3
People taking part
400 people, planned
Started
20 Dec 2023
Expected to end
31 Oct 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • lisaftoclax +BTK inhibitor
  • BTK inhibitor
Record updated
18 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have already been treated with a BTK inhibitor alone for at least 12 months.

Age
18 to 99 years
Sex
All sexes can join.
Disease stage
CLL/SLL that meets the iwCLL 2018 criteria for starting treatment. ECOG performance status of 0-2.
Earlier treatment
Must have received BTK inhibitor treatment alone (monotherapy) for at least 12 months.

Main reasons for not taking part

  • Low blood counts: neutrophils below 1.0 × 109/L, platelets below 75 × 109/L, or hemoglobin below 9 g/dL
  • Kidney function too low: creatinine clearance of 50 ml/min or less
  • Liver tests too high: total bilirubin above 1.5 x ULN, or AST or ALT above 2.5 x ULN
  • Blood clotting tests (INR, PT or APTT) above 1.5×ULN
  • Cannot give written informed consent or follow the study visit schedule

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 99 years old?

Where in Russia

Also in 19 other countries, 135 sites

  • KalugaHospital not named in the registryContact: Shanthi Marur, MDNo longer taking part
  • Kazan'Hospital not named in the registryContact: Shanthi Marur, MDNo longer taking part
  • Kirov, Kirov OblastHospital not named in the registryContact: Shanthi Marur, MDNo longer taking part
  • MoscowHospital not named in the registryContact: Shanthi Marur, MDNo longer taking part
  • PetrozavodskHospital not named in the registryContact: Shanthi Marur, MDNo longer taking part
  • Saint Petersburg, Kaluga OblastHospital not named in the registryContact: Shanthi Marur, MDNo longer taking part
  • SochiHospital not named in the registryContact: Shanthi Marur, MDNo longer taking part
  • SyktyvkarHospital not named in the registryContact: Shanthi Marur, MDNo longer taking part

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Arm 1Existing treatment, for comparison

    Combination therapy

    Treatment: lisaftoclax +BTK inhibitor

  • Arm 2Existing treatment, for comparison

    mono therapy

    Treatment: BTK inhibitor

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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)
Plain-language title
Tests lisaftoclax with a BTK inhibitor in adults with previously treated CLL or SLLGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT06104566, who can take part
Record updated
18 June 2026