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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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Title:

Venetoclax and Ibrutinib in Treating Patients With Chronic or Small Lymphocytic Leukemia

Excerpt:
...- Cohort 2: Untreated patients with high-risk features (del(17p), or mutated TP53, or del(11q), or unmutated IGHV, or >= 65 years of age) are eligible (cohort 2) provided they have active disease requiring treatment as defined by the International Working Group for CLL (IWCLL)...
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Ibrutinib Plus Venetoclax for First-line Treatment of Chronic Lymphocytic Leukemia

Published date:
06/10/2021
Excerpt:
Patients were required to have at least 1 of the following features: del(17p), TP53-mutated CLL, del(11q)...Therapy consisted of ibrutinib, 420 mg/d, monotherapy for 3 cycles, thereafter combined with venetoclax....The 3-year progression-free survival was 93%, and 3-year overall survival was 96%....Remissions appeared to be durable during a follow-up of more than 3 years, with activity seen across high-risk disease subgroups, including those with del(17p)/TP53-mutated CLL.
DOI:
10.1001/jamaoncol.2021.1649
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

The Addition of Venetoclax to Ibrutinib Achieves a High Rate of Undetectable Minimal Residual Disease in Patients with High-Risk CLL

Published date:
11/04/2020
Excerpt:
We designed a phase II, investigator-initiated, response-adapted clinical trial with the addition of ven to ibr in patients (pts) with one or more high risk features...High risk was defined as any of: del(17p); complex karyotype; del(11q); elevated β2-microglobulin; TP53 mutation....Ven added to ibr in pts with high-risk CLL as consolidation was well tolerated and associated with a high likelihood of achieving U-MRD in BM and CR within 12 months of combination.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Ibrutinib (Ibr) Plus Venetoclax (Ven) for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): Results from the MRD Cohort of the Phase 2 CAPTIVATE Study

Published date:
11/06/2019
Excerpt:
The high rates of BM uMRD were consistent across high-risk subgroups, including in pts with del(17p) (75%), del(17p) or TP53 mutation (70%), del(11q) (84%), complex karyotype (83%), and unmutated IGHV status (81%)... First-line treatment with Ibr + Ven represents an all oral, once-daily, chemotherapy-free regimen that provides high rates of uMRD in both PB and BM in pts with CLL.
DOI:
10.1182/blood-2019-121424
Trial ID: