After the ibrutinib lead-in, the risk of 90% of the patients whose risk for tumor lysis syndrome was high at baseline shifted to a medium or low risk, underscoring that this is a highly effective strategy for reducing the risk for tumor lysis. SO One finding was that the 3 cycles of ibrutinib worked as expected to reduce the risk for tumor lysis syndrome. H&O Could you describe the results of CAPTIVATE? Dr Paolo Ghia presented these results at the 2021 virtual annual meeting of the American Society of Clinical Oncology. In the second cohort, called the fixed-duration cohort, 159 patients received no further treatment after the initial 15 months of treatment.
Dr William Wierda presented the results of the MRD cohort at the 2020 virtual annual meeting of the American Society of Hematology. The primary endpoint was 1-year disease-free survival (DFS) after randomization. Those who had confirmed undetectable MRD assessed at a limit of detection of 10 -4 were randomly assigned in a double-blind fashion to ibrutinib or placebo, and those who did not have confirmed undetectable MRD were randomly assigned in a 1:1 ratio to open-label ibrutinib or continued ibrutinib plus venetoclax. The idea behind the ibrutinib lead-in, which has become standard in randomized trials of combination treatment in CLL, is to debulk the tumor, thereby reducing the risk for tumor lysis during the venetoclax ramp-up.Īfter the initial 15 months of treatment, 164 patients in the first cohort-called the minimal residual disease (MRD) cohort-were tested for MRD. All patients were younger than 70 years and received 3 months of standard-dose (420 mg) ibrutinib (Imbruvica, Pharmacyclics/Janssen) followed by 12 cycles of fixed-duration ibrutinib plus venetoclax (Venclexta, AbbVie), with venetoclax ramped up to the standard dose (400 mg).
Captivate for mac trial trial#
SO CAPTIVATE is a phase 2 trial in patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). H&O Could you describe the design of the CAPTIVATE trial?
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