CLL Recruiting Clinical Trials: MAJIC Study Acalabrutinib + Venetoclax

One of the current recruiting clinical trials for CLL patients is the MAJIC study. The study's goal is to find the best venetoclax treatment combination by reviewing which therapy combination is more effective; combining acalabrutinib (BTK inhibitor, newer and better tolerated than the original BTKi ibrutinib) with venetoclax (BCL2 inhibitor) or the currently approved combination of venetoclax with obinutuzumab (monoclonal antibody) for previously untreated CLL/SLL patients. Acalabrutinib is currently approved to be taken by itself but not yet in combination with venetoclax. 

Reasons to Conduct the MAJIC Study

BTK inhibitors, venetoclax, and monoclonal antibodies have proven effective in treating CLL compared to previously used chemoimmunotherapy. Researchers are looking to continue to improve treatment for CLL patients. Current issues experts are seeing with the newer targeted therapies are that patients taking a BTKi by itself long-term can create long-term side effects, it is expensive to take long term, and many patients become resistant to the treatment over time. 

The downside of venetoclax + antibody treatment is the antibody portion is administered by infusion which can be inconvenient. Researchers have also seen that about 25% of CLL patients taking venetoclax + an antibody don’t achieve undetectable minimal residual disease (uMRD) within the treatment’s fixed time frame (1 year for previously untreated or 2 years for previously treated). 

Researchers found that combining BTKis with venetoclax has shown promising results to achieve deep remissions for CLL patients. This was evaluated in the GLOW and CAPTIVATE trials studying the first BTKi ibrutinib combined with venetoclax. Although effective, ibrutinib caused many side effects. The MAJIC study looks to use the newer BTKi acalabrutinib which has a better safety profile than ibrutinib.    

Joining the MAJIC Study 

The study is currently in phase III (meaning the study’s goal is to compare the safety and effectiveness of current treatments against the new treatment). Patients enrolled are split evenly between the two groups and continue the treatment regimen for a maximum of two years. CLL patients can see if they qualify to enroll by reviewing the inclusion and exclusion criteria found about halfway through the clinical trial’s page: MAJIC clinical trial NCT05057494. If patients have questions about eligibility requirements, they can reach out to the AstraZeneca's Clinical Study contact at 1-877-240-9479 or email them at information.center@astrazeneca.com. 

Recruiting locations include:

• Tucson, Arizona, 85710
• Longmont, Colorado, 80501
• Jacksonville, Florida, 32256
• Boston, Massachusetts, 02115
• New Hyde Park, New York, 11040
• New York, New York, 10065
• Charlotte, North Carolina, 28204
• Cleveland, Ohio, 44195
• Eugene, Oregon, 97401
• Nashville, Tennessee, 37203
• Salt Lake City, Utah, 84112
• Charlottesville, Virginia, 22908

For recruiting locations outside of the U.S. like Australia, Czechia, Hungary, Poland, and Spain, see here: MAJIC clinical trial NCT05057494.