Lisaftoclax with BTK Inhibitors for CLL/SLL Patients
Global Trial in APG2575 for Patients With CLL/SLL
Recruiting
Phase 3Interventional Study
CLL/SLL
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 99
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
Ascentage Pharma Group Inc. · Industry
Who this trial is looking for
This trial is looking for adults with chronic lymphocytic leukemia or small cell lymphoma who have been treated with a BTK inhibitor for at least 12 months. Participants will take part in research on a new treatment combination that aims to improve their condition.
Are You a Good Fit for This Trial?
Must be takingBTK inhibitor
You may be able to join if
I am at least 18 years old.
I have been diagnosed with chronic lymphocytic leukemia (CLL) or small cell lymphoma (SLL).
I have been on BTK inhibitor treatment for at least 12 months.
I have a good performance status (ECOG grade 0-2).
I have enough healthy bone marrow.
I have adequate kidney function.
I have adequate liver function.
I can give written consent and follow the study requirements.
You may not be able to join if
I have known Gilbert's Syndrome.
My kidney function is not adequate.
I have not been on BTK inhibitor treatment for at least 12 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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
Trial Locations
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Eligibility Criteria
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 in…
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
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