Edward Cliff, Haematology Registrar at Peter MacCallum Cancer Centre and The Royal Melbourne Hospital, shared a post on LinkedIn about a paper he co-authored with colleagues publushed in the Journal of Clinical Oncology:
“Just out in JCO.
We review the BRUIN-CLL-321 randomised controlled trial of pirtobrutinib versus idelalisib-rituximab or bendamustine-rituximab for R/R CLL.
We highlight lessons from:
- choice of control arm
- early withdrawals/discontinuations and informative censoring
- endpoint discrepancies – investigator vs IRC assessed, PFS vs TTNT
- the nuances (and incentives) of crossover in an open-label trial
Pirtobrutinib is a highly effective drug and a welcome addition to the treatment of CLL – but this trial offers a few opportunities for reflection on trial design.
Hope you enjoy.”
Title: Optimizing Control Arms in Chronic Lymphocytic Leukemia Clinical Trials: The BRUIN-CLL-321 Trial
Authors: Edward R. Scheffer Cliff, Thomas E. Lew, Florian Simon, Talal Hilal, Mary Ann Anderson, Philip A. Thompson, and John F. Seymour
You can read the Full Article in the Journal of Clinical Oncology.
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