AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Global Trial in APG2575 for Patients With CLL/SLL

RecruitingPhase 3Ages 18 Years - 99 YearsAllAscentage Pharma Group Inc.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ 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 โ‰ฅ 1.0 ร— 109/L * Platelet counts โ‰ฅ 75 ร— 109/L; in cases of thrombocytopenia * Total hemoglobin โ‰ฅ 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 โ‰ˆ ((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 โ‰ค 1.5 x ULN, except patients with known Gilbert's Syndrome * Aspartate aminotransferase (AST) โ‰ค 2.5 x the institutional ULN value * Alanine aminotransferase (ALT) โ‰ค 2.5 x the institutional ULN value, * International normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT) โ‰ค 1.5ร—ULN. 7. Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements
๐Ÿ’Š

What it tests

  • lisaftoclax +BTK inhibitor
  • BTK inhibitor
๐Ÿ“

Where

135 sites
Ascentage Investigative Site
Tuscon, United States
Ascentage Investigative Site
Anaheim, United States
Ascentage Investigative Site
Jacksonville, United States
Ascentage Investigative Site
Miami Beach, United States
Ascentage Investigative Site
Peoria, United States
Ascentage Investigative Site
Boston, United States
Ascentage Investigative Site
Ann Arbor, United States
Ascentage Investigative Site
Greenville, United States

โ€ฆand 127 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy