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New treatment option for CLL/SLL
Official title Global Trial in APG2575 for Patients With CLL/SLL
ClinicalTrials.gov ID: NCT06104566
What this study is testing
What is lisaftoclax +BTK inhibitor?
lisaftoclax +BTK inhibitor is an investigational medicine, being studied as a potential treatment for cll/sll.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Age ≥ 18 years.
- Patients that have documented CLL/SLL who meet iwCLL 2018 criteria for CLL treatment guidelines are eligible for treatment and must be receiving BTKi...
- ECOG Performance Status grade 0-2
- 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
See the full eligibility criteria
- Age ≥ 18 years.
- 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
- ECOG Performance Status grade 0-2
- 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,
- 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...
- 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...
- 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.
- Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements
The study team makes the final eligibility decision.
Where it's taking place
- Tuscon, Arizona, United States
- Anaheim, California, United States
- Jacksonville, Florida, United States
- Miami Beach, Florida, United States
- Peoria, Illinois, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Greenville, North Carolina, United States
- Houston, Texas, United States
- Kingswood, Texas, United States
- Richmond, Virginia, United States
- Gosford, Australia
- Perth, Australia
- Westmead, Australia
- Ghent, Belgium
- La Louvière, Belgium
- Leuven, Belgium
- Ottignies, Belgium
- Roeselare, Belgium
- Sofia, Bulgaria
+ 99 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tuscon, Arizona, United States; Anaheim, California, United States; Jacksonville, Florida, United States; Miami Beach, Florida, United States; Peoria, Illinois, United States; Boston, Massachusetts, United States and 113 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.