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What were the results of the phase 3 gaia CLL13 trial [2023]?

Barbara Eichhorst, MD Professor of Medicine at UNIVERSITÄTSKLINIKUM KÖLN, is the author of this OncologyTube.com video.

Timestamps:

0:09 Can you tell us about the CELL Trial and it´s design and any significant data.

3:04 How many patients were enrolled in the study and what were the characteristics of the patient population?

3:55 Can you touch on any adverse events that were seen in the study?

5:18 What are the common questions you’re asked by your colleagues about this data?

6:59 What are the key takeaways that you’d like to leave are oncologists viewers with and any final thoughts?

7:45 Is this going to affect clinicians in the future?

In Phase 3 of this clinical trial, researchers are striving to supplant conventional chemoimmunotherapy (FCR, BR) with precise combinations of targeted drugs (Venetoclax, Ibrutinib) along with anti-CD20 antibodies (Rituximab, Obinutuzumab) for CLL patients lacking specific mutations. 

The primary focus of this study revolves around achieving MRD negativity and enhancing progression-free survival rates. The trial encompasses 926 participants, all aged 18 or above, who are afflicted with CLL and necessitate treatment.

The anticipated culmination of this research is projected for February 2025. This investigation aims to unveil safer and more efficacious options for frontline therapy.

The study compared different treatment arms, including kimunos therapy, seafood-based regimens, and combinations involving CD20 antibodies. The primary endpoints of the trial were focused on the undetectable rate of minimal residual disease and progression-free survival.

Barbara Eichhorst, MD reported significant findings from the study, showcasing the effectiveness of various treatment approaches. Notably, a combination of venetoclax and obinutuzumab yielded high response rates and excellent disease control, particularly in younger and fitter patients. The study also revealed important considerations regarding infection rates and adverse events associated with different treatment arms.

Clinicians were advised to consider the long-term implications of treatment, including potential secondary cancers. Dr. Eichhorst stressed the importance of continued patient follow-up and encouraged participation in registries for comprehensive data collection.

The interview shed light on the evolving landscape of CLL treatment, providing oncologists with valuable insights for informed decision-making and patient care.

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