Global Trial in APG2575 for Patients With CLL/SLL

Launched by ASCENTAGE PHARMA GROUP INC. · Oct 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The trial is testing a medication called APG2575, which is being used alongside other drugs known as BTK inhibitors. This research aims to find out how effective and safe this combination treatment is for patients who have already been on BTK inhibitors for at least a year.

To participate in the trial, patients need to be at least 18 years old and have a confirmed diagnosis of CLL or SLL. They should also have good overall health, as shown by specific blood tests, and must be receiving BTK inhibitor treatment. The study is currently looking for participants, and those who join can expect regular visits to monitor their health and the effects of the treatment. It's important that participants can understand the study and agree to follow the guidelines and attend the scheduled appointments.

Gender

ALL

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 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