CLL/SLL study: Lisaftoclax +BTK inhibitor vs BTK inhibitor
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?
This is an investigational combination of two medicines being studied as a potential treatment for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Lisaftoclax is designed to stop the growth of cancer cells by blocking a protein called BCL-2, while the BTK inhibitor is designed to block a signal that helps cancer cells survive.
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
- The study aims to see how well and how safely lisaftoclax works when added to BTK inhibitors in patients with CLL or SLL who have been treated before with BTK drugs.
- Who it's for
- Adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously received BTK inhibitor therapy.
- What's involved
- Participants will receive lisaftoclax together with their current BTK inhibitor, and will have regular clinic visits and medical tests to monitor response and side effects.
- Time commitment
- The trial lasts several months, with scheduled visits and tests throughout the study period.
- 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
- Absolute neutrophil count ≥ 1.0 × 109/L
- Platelet counts ≥ 75 × 109/L; in cases of thrombocytopenia
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
- 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.
- 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 is enrolling
- 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
- Ghent, Belgium
- La Louvière, Belgium
- Leuven, Belgium
- Ottignies, Belgium
- Roeselare, Belgium
- Sofia, Bulgaria
- Halifax, Nova Scotia, Canada
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
+ 87 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, but 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?
This study is enrolling now at 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 101 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.