Application of a sequential multiple assignment randomized trial (SMART) design in older patients with chronic lymphocytic leukemia

摘要

Background: Ibrutinib therapy is safe and effective in patients with chronic lymphocytic leukemia (CLL). Currently, ibrutinib is administered continuously until disease progression. Combination regimens with ibrutinib are being developed to deepen response which could allow for ibrutinib maintenance (IM) discontinuation. Among untreated older patients with CLL, clinical investigators had the following questions: (i) does ibrutinib thorn venetoclax thorn obinutuzumab (IVO) with IM have superior progression-free survival (PFS) compared with ibrutinib thorn obinutuzumab (IO) with IM, and (ii) does the treatment strategy of IVO thorn IM for patients without minimal residual disease complete response (MRD-CR) or IVO thorn IM discontinuation for patients with MRD-CR have superior PFS compared with IO thorn IM.