Acalabrutinib for Chronic Lymphocytic Leukemia
Trial Summary
What is the purpose of this trial?
This study is evaluating the safety and efficacy of a new BTK inhibitor, acalabrutinib, for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take proton-pump inhibitors or certain blood thinners like warfarin within 7 days of starting the study drug. If you're on these medications, you may need to discuss alternatives with your doctor.
What data supports the effectiveness of the drug Acalabrutinib for treating Chronic Lymphocytic Leukemia?
Research shows that Acalabrutinib, a drug that targets a specific protein involved in cancer cell growth, significantly extends the time patients live without their disease getting worse compared to standard treatments. It has been approved in the EU and the US for both newly diagnosed and previously treated patients, demonstrating improved safety and effectiveness.12345
Is acalabrutinib safe for humans?
Acalabrutinib, also known as Calquence, has been shown to have a generally favorable safety profile in patients with chronic lymphocytic leukemia, though it may increase the risk of certain side effects like neutropenia (low white blood cell count), leukopenia (low white blood cell count), and cardiac events such as atrial fibrillation (irregular heartbeat). Most common side effects include headache, diarrhea, and infections, but the overall benefit-risk ratio is considered positive.12367
How is the drug Acalabrutinib unique for treating chronic lymphocytic leukemia?
Acalabrutinib is unique because it is a highly selective Bruton tyrosine kinase inhibitor, which means it specifically targets a protein that helps cancer cells grow and survive, leading to longer progression-free survival compared to some standard treatments. It is taken orally and has a favorable safety profile, making it a promising option for both newly diagnosed and relapsed patients.12348
Research Team
Acerta Clinical Trials
Principal Investigator
1-888-292-9613 acertamc@dlss.com
Eligibility Criteria
This trial is for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who need treatment, have specific symptoms like anemia or large spleen, and haven't responded well to other therapies. It's also for those intolerant to a drug called ibrutinib. People can't join if they've had certain recent treatments, uncontrolled heart issues, active infections like HIV/HBV/HCV, severe bleeding disorders, major surgery within the last month, or are pregnant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral acalabrutinib in various dosing regimens until disease progression or intolerance
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Acalabrutinib
Acalabrutinib is already approved in United States, European Union for the following indications:
- Mantle cell lymphoma
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
- Mantle cell lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Acerta Pharma BV
Lead Sponsor