Global Trial in APG2575 for Patients With CLL/​SLL

Overview

About this study

The purpose of this study is to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL/SLL patients who previously treated with BTK inhibitors

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

 

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 08/19/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Sikander Ailawadhi, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available