Risk-adapted, ofatumumab-based chemoimmunotherapy and consolidation in treatment-naive chronic lymphocytic leukemia: a phase 2 study.

ABSTRACT: High-risk cytogenetics and minimal residual disease (MRD) after chemoimmunotherapy (CIT) predict unfavorable outcome in chronic lymphocytic leukemia (CLL). This phase 2 study investigated risk-adapted CIT in treatment-naïve CLL (NCT01145209). Patients with high-risk cytogenetics received induction with fludarabine, cyclophosphamide, and ofatumumab. Those without high-risk cytogenetics received fludarabine and ofatumumab. After induction, MRD positive (MRD+) patients received 4 doses of ofatumumab consolidation. MRD negative (MRD-) patients had no intervention. Of 28 evaluable for response, all responded to induction and 10 (36%) achieved MRD-. Two-year progression-free survival (PFS) was 71.4% (CI₉₅, 56.5-90.3%). There was no significant difference in median PFS between the high

SUBMITTER: Desai S 

PROVIDER: S-EPMC9250410 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature