Investigating a new treatment for patients with CLL/SLL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global multicenter, open-label, randomized phase III study aims to evaluate the efficacy and safety of lisaftoclax in combination with BTK inhibitors for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with BTK inhibitors. Approximately 440 eligible patients will be randomly assigned in a 1:1 ratio to receive either the combination treatment or a BTK inhibitor alone. The study focuses on patients who have been on BTK inhibitor monotherapy for at least 12 months and meet specific eligibility criteria related to their health status and laboratory values.

Why it matters

Who can join: the full rules

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

Where it's running

• Ascentage Investigative Site
  Tuscon, Arizona, United States Recruiting
• Ascentage Investigative Site
  Anaheim, California, United States Recruiting
• Ascentage Investigative Site
  Jacksonville, Florida, United States Recruiting
• Ascentage Investigative Site
  Miami Beach, Florida, United States Recruiting
• Ascentage Investigative Site
  Peoria, Illinois, United States Recruiting
• Ascentage Investigative Site
  Boston, Massachusetts, United States Recruiting

+85 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Shanthi Marur, MD
• Email: shanthi.marur@ascentage.com
• Phone: 3017925062

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Epcoritamab given after 2nd-generation BTK inhibitors for CLL/SLL

  This trial will try giving subcutaneous epcoritamab for up to 12 cycles to adults with CLL/SLL who have been on a second‑generation BTK inhibitor for at least 12 months to see if it can deepen responses to a complete remission with undetectable MRD so therapy can be stopped.

  Recruiting Phase 2 University of Cincinnati · Cincinnati, Ohio · NCT07108998

• LP-168 plus obinutuzumab for previously treated and BTK T474I‑mutated CLL/SLL

  This trial tests whether adding LP-168 to obinutuzumab helps people with previously treated CLL/SLL, including those with the BTK T474I gatekeeper mutation, achieve deeper remissions.

  Recruiting Phase 2 University of Cincinnati · Cincinnati, Ohio · NCT06978088

• Combining Lisaftoclax and Acalabrutinib for Newly Diagnosed CLL/SLL

  This study is testing if a new combination of two drugs, Lisaftoclax and Acalabrutinib, can work better than standard treatment for people who have just been diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma.

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• Combining venetoclax with epcoritamab for treating relapsed or refractory CLL or SLL

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  Recruiting at 25 sites Phase 1/2 Stichting Hemato-Oncologie voor Volwassenen Nederland · Melbourne and 28 other locations · NCT05791409

• Oral treatment with LP-168 for patients with certain blood cancers

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  Recruiting at 4 sites Phase 1 Newave Pharmaceutical Inc · Durham, North Carolina and 3 other locations · NCT04775745

• Retreatment with venetoclax and acalabrutinib for relapsed CLL

  This study is testing if a new combination of venetoclax and acalabrutinib can help people with relapsed chronic lymphocytic leukemia (CLL) achieve better treatment results after their previous therapy.

  Recruiting at 18 sites Phase 2 Stichting Hemato-Oncologie voor Volwassenen Nederland · Brussels and 17 other locations · NCT04523428

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.