Long-term immune reconstitution and final 1-year follow-up after fixed-duration venetoclax-obinutuzumab (VenO) in first-line (1L) chronic lymphocytic leukemia (CLL): Results from the Phase III CRISTALLO trial
Phase III CRISTALLO trial shows venetoclax-obinutuzumab improves minimum residual disease rates in chronic lymphocytic leukemia, highlighting immune reconstitution benefits.
Key Points
To evaluate long-term immune reconstitution and clinical outcomes following fixed-duration venetoclax-obinutuzumab in first-line chronic lymphocytic leukemia.
Randomized 1:1 trial comparing venetoclax-obinutuzumab with FCR/BR in treatment-naïve patients.
Primary endpoint was undetectable minimum residual disease at Month 15 in peripheral blood.
Immune profiling conducted at baseline, during treatment, and post-treatment up to 48 months.
81.3% of patients on venetoclax-obinutuzumab achieved undetectable MRD at Month 15 vs 54.7% with FCR/BR.
CLL cells remained suppressed up to 36 months in uMRD group, while MRD+ group saw rapid CLL cell rebound.
Partial recovery of non-malignant B cells occurred in MRD+ group, with significant Ig level declines followed by gradual recovery.