Lisaftoclax + BTK Inhibitors for CLL
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Researchers aim to determine if adding a drug called lisaftoclax to BTK inhibitors (a type of cancer treatment) improves outcomes for patients who have used BTK inhibitors alone for at least a year. Individuals diagnosed with CLL or SLL and using BTK inhibitors for over 12 months might be suitable candidates. The trial evaluates the effectiveness and safety of this new combination compared to continuing with the BTK inhibitor alone. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it does require that you have been on BTK inhibitor monotherapy for at least 12 months. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In previous studies, patients with chronic lymphocytic leukemia (CLL) have tolerated lisaftoclax well. Among 176 patients, only five (2.8%) experienced a serious side effect called tumor lysis syndrome, which occurs when cancer cells break down too quickly. This indicates that most patients managed the treatment without major problems.
BTK inhibitors, such as acalabrutinib, have a strong safety record. These drugs are already approved for treating CLL and have transformed how doctors approach this disease. In real-world use, people taking these drugs have generally fared well. Overall, past research shows that the treatments in this trial are safe.12345Why are researchers excited about this trial's treatments?
Lisaftoclax is unique because it targets the BCL-2 protein, which helps cancer cells survive. This approach is different from most current treatments for Chronic Lymphocytic Leukemia (CLL) that primarily focus on inhibiting Bruton's tyrosine kinase (BTK), like ibrutinib. Researchers are excited about the potential of combining lisaftoclax with BTK inhibitors because it could attack CLL from two angles, potentially leading to more effective results. Additionally, using lisaftoclax as monotherapy offers a new mechanism of action for patients who may not respond well to existing BTK inhibitors. This dual approach could improve outcomes and offer new hope for patients with CLL.
What evidence suggests that this trial's treatments could be effective for CLL/SLL?
This trial will compare lisaftoclax alone and in combination with BTK inhibitors for treating chronic lymphocytic leukemia (CLL). Research has shown that lisaftoclax, both alone and with BTK inhibitors, holds promise for CLL treatment. Studies have found that lisaftoclax works well in patients who have already received treatment, with many showing significant improvements. In one study, about 88% of patients had CLL that returned or didn't respond to initial treatment, yet lisaftoclax still showed strong results. Combining lisaftoclax with BTK inhibitors might enhance these effects, as BTK inhibitors are already known to be effective in CLL. Overall, the combination aims to use the strengths of each treatment to provide a more powerful approach.678910
Are You a Good Fit for This Trial?
This trial is for patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have been treated with BTK inhibitors for at least a year. They must meet specific health criteria like having enough hemoglobin, neutrophils, and platelets, as well as proper kidney function and performance status.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lisaftoclax in combination with a BTK inhibitor or BTK inhibitor alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BTK Inhibitor
- Lisaftoclax
Trial Overview
The study is testing the effectiveness of lisaftoclax combined with BTK inhibitors in CLL/SLL patients previously treated with just BTK inhibitors. It's a phase III trial where participants are openly assigned to treatments to see if the combination works better.
How Is the Trial Designed?
2
Treatment groups
Active Control
Combination therapy
mono therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ascentage Pharma Group Inc.
Lead Sponsor
Citations
1.
ashpublications.org
ashpublications.org/blood/article/142/Supplement%201/1900/500060/Updated-Efficacy-and-Safety-Results-of-LisaftoclaxUpdated Efficacy and Safety Results of Lisaftoclax (APG-2575 ...
Lisaftoclax demonstrated significant efficacy at 400, 600, and 800 mg, and potentially 200 mg, in pts with R/R CLL who were heavily pretreated ...
An Update on Lisaftoclax for CLL
An Update on Lisaftoclax for CLL · A total of 176 patients enrolled in the trial; 88% were relapsed / refractory and 12% were treatment-naïve.
Press Releases
Early data from the studies have demonstrated effects on hematologic malignancies and solid tumors. Lisaftoclax is being commercialized in China ...
Safety, tolerability, and pharmacokinetics of lisaftoclax ...
Of 176 patients, 154 (87.5%) had relapsed/refractory and 22 (12.5%) treatment-naive CLL. Five patients (2.8%) experienced tumor lysis syndrome ( ...
Novel BCL-2 Inhibitor Lisaftoclax in Relapsed or Refractory ...
A total of 14 of 22 evaluable patients with CLL/SLL had a partial response (PR) per 2008 International Workshop on CLL criteria over a median of 15 (range, 6-43) ...
6.
ashpublications.org
ashpublications.org/blood/article/142/8/679/497461/BTK-inhibitors-safety-efficacy-outcomeBTK inhibitors: safety + efficacy = outcome
Approved covalent Bruton tyrosine kinase (BTK) inhibitors like ibrutinib and acalabrutinib have changed the treatment paradigm for CLL.
Real-world efficacy and safety outcomes of acalabrutinib in ...
Acalabrutinib is a second-generation BTK inhibitor approved for the treatment of chronic lymphocytic leukemia (CLL) after demonstrating efficacy ...
Real-World Safety Data for BTK Inhibitors in CLL from EHA ...
Marc S. Hoffmann, MD, and Mazyar Shadman, MD, MPH, discuss real-world safety data for BTK inhibitors in chronic lymphocytic leukemia from EHA
Pirtobrutinib after a Covalent BTK Inhibitor in Chronic ...
The median progression-free survival was 19.6 months (95% CI, 16.9 to 22.1). Among all 317 patients with CLL or SLL who received pirtobrutinib, ...
Efficacy and safety of first- versus second-generation ...
The results showed that 24-month PFS was 87% and overall response was 86% for acalabrutinib monotherapy. In the SEQUOIA study, Tam et al. (2022) ...
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