Fixed-duration VenO vs FCR/BR in fit patients with untreated CLL: primary analysis of the phase 3 CRISTALLO trial - PubMed
6 hours ago
- #Clinical Trial
- #CLL
- #Venetoclax-Obinutuzumab
- The phase 3 CRISTALLO trial compared first-line fixed-duration venetoclax-obinutuzumab (VenO) vs fludarabine, cyclophosphamide, and rituximab (FCR)/bendamustine-rituximab (BR) in untreated CLL patients.
- Primary endpoint was undetectable minimal residual disease (uMRD) in peripheral blood at month 15, with VenO showing 81.3% vs FCR/BR 54.7% (P = .0004).
- uMRD rates in both peripheral blood and bone marrow at end of treatment were higher with VenO compared to FCR/BR.
- Fewer patients progressed or died with VenO (7) vs FCR/BR (13), though follow-up was short for PFS evaluation.
- At month 15, 65.0% (VenO) and 25.6% (FCR/BR) achieved deeper uMRD (<10-6) in peripheral blood.
- Safety profiles were consistent with known drug profiles; no clinical tumor lysis syndrome occurred in the VenO arm.
- Results validate findings from GAIA-CLL13, showing increased depth of response with VenO over chemoimmunotherapies.