Dr. Shadman on the CLL14 Trial in CLL

Mazyar Shadman, MD, MPH
Published: Friday, Jul 19, 2019



Mazyar Shadman, MD, MPH, assistant member, Clinical Research Division, Fred Hutchinson Cancer Research Center, assistant professor, Medical Oncology Division, University of Washington School of Medicine, and attending physician, Hematologic Malignancies, Seattle Cancer Care Alliance, discusses the phase III CLL14 trial in chronic lymphocytic leukemia (CLL).

At the 2019 ASCO Annual Meeting, the results of the German CLL14 trial were presented. In the trial, treatment-naïve patients were randomized to receive the combination of venetoclax (Venclexta) and obinutuzumab versus chlorambucil and obinutuzumab. The combination with venetoclax resulted in a significant improvement in progression-free survival versus the combination of chlorambucil and obinutuzumab. These data have since become the most important data in CLL since the 2018 ASH Annual Meeting, says Shadman.

The study served as the basis for the FDA approval of venetoclax in the frontline setting. The study was designed to include patients with comorbidities and patients who did not have perfect kidney function. However, the combination is approved for use in all patients with CLL. Although the study was designed for a specific subpopulation, every patient is likely to see a benefit from it, Shadman concludes.
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Mazyar Shadman, MD, MPH, assistant member, Clinical Research Division, Fred Hutchinson Cancer Research Center, assistant professor, Medical Oncology Division, University of Washington School of Medicine, and attending physician, Hematologic Malignancies, Seattle Cancer Care Alliance, discusses the phase III CLL14 trial in chronic lymphocytic leukemia (CLL).

At the 2019 ASCO Annual Meeting, the results of the German CLL14 trial were presented. In the trial, treatment-naïve patients were randomized to receive the combination of venetoclax (Venclexta) and obinutuzumab versus chlorambucil and obinutuzumab. The combination with venetoclax resulted in a significant improvement in progression-free survival versus the combination of chlorambucil and obinutuzumab. These data have since become the most important data in CLL since the 2018 ASH Annual Meeting, says Shadman.

The study served as the basis for the FDA approval of venetoclax in the frontline setting. The study was designed to include patients with comorbidities and patients who did not have perfect kidney function. However, the combination is approved for use in all patients with CLL. Although the study was designed for a specific subpopulation, every patient is likely to see a benefit from it, Shadman concludes.

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