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Association details:
Evidence:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Outcomes in Patients with High-Risk Features after Fixed-Duration Ibrutinib plus Venetoclax: Phase II CAPTIVATE Study in First-Line Chronic Lymphocytic Leukemia

Published date:
07/14/2023
Excerpt:
In subsets with del(17p)/TP53 mutation (n = 29) CR rates were 52%...Thirty-six-month overall survival (OS) rates were >95% regardless of high-risk features...Deep, durable responses and sustained PFS seen with fixed-duration ibrutinib plus venetoclax are maintained in patients with high-risk genomic features, with similar PFS and OS to those without high-risk features.
DOI:
10.1158/1078-0432.CCR-22-2779
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Outcomes in Patients with High-Risk Features after Fixed-Duration Ibrutinib plus Venetoclax: Phase II CAPTIVATE Study in First-Line Chronic Lymphocytic Leukemia

Published date:
06/07/2023
Excerpt:
Patients received three cycles of ibrutinib 420 mg/day then 12 cycles of ibrutinib plus venetoclax...36-month progression-free survival (PFS) rates: 88% and 92% in subsets with del(17p)/TP53 mutation (n = 29)...Deep, durable responses and sustained PFS seen with fixed-duration ibrutinib plus venetoclax are maintained in patients with high-risk genomic features, with similar PFS and OS to those without high-risk features.
DOI:
10.1158/1078-0432.CCR-22-2779
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Fixed-duration ibrutinib + venetoclax for first-line treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): 4-y follow-up from the FD cohort of the phase 2 CAPTIVATE study.

Published date:
05/25/2023
Excerpt:
Pts aged ≤70 y with previously untreated CLL/SLL received 3 cycles of I then 12 cycles of I+V (I 420 mg/d orally; V ramp-up to 400 mg/d orally)….4 y PFS rates were numerically lower in pts with uIGHV (73%) or del(17p) and/or TP53 mutation (63%), while OS rates remained consistently high (Table)....With 4 y follow-up, fixed-duration I+V continues to provide deep, durable remissions with clinically meaningful PFS and time off treatment, including in pts with high-risk disease features.
DOI:
10.1200/JCO.2023.41.16_suppl.7535
Trial ID: