A Phase II Multi-Center Trial
Montillo M, Rossi D, Motta M, et al.




Key Points:
  • Phase II trial to assess Pentostatin, Cyclophosphamide and Ofatumumab x 6 cycles in therapy requiring elderly CLL patients

  • Primary endpoint: overall response rate (ORR) including detection of minimal residual disease (MRD)

  • Secondary endpoints: progression-free survival (PFS), overall survival (OS) and safety

  • ORR:93.7%, CR: 41%

  • 94% patients received 6 cycles, 90% of these patients received full-dose treatment

  • Primary reason for discontinuing treatment/dose reduction: myelosuppression

  • Grade ≥3 AEs was neutropenia (62%)

  • No deaths occurred during treatment.

Implications:

  • Efficacy of ofatumumab-based chemoimmunotherapy (CIT) compares favorably to historical rituximab-based CIT with more manageable side effect profile in older population.
Additional Comments:
  • Further data in higher number of enrolled patients and including MRD detection to be presented at ASH.

View the original abstract on the ASH website.






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