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Association details:
| Biomarker: | TP53 mutation |
|---|---|
| Cancer: | Chronic Lymphocytic Leukemia |
| Drug: | Venclexta (venetoclax) (Bcl2 inhibitor) + Imbruvica (ibrutinib) (BTK inhibitor) + Gazyva (obinutuzumab) (CD20 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Final analysis of the CLL2-GIVe trial: obinutuzumab, ibrutinib, and venetoclax for untreated CLL with del(17p)/TP53mut
Published date:
09/14/2023
Excerpt:
The final analysis of the open-label, multicenter phase 2 CLL2-GIVe trial shows response and tolerability of the triple combination of obinutuzumab, ibrutinib, and venetoclax (GIVe regimen) in 41 previously untreated patients with high-risk chronic lymphocytic leukemia (CLL) with del(17p) and/or TP53 mutation...The primary end point was the complete remission rate at cycle 15, which was achieved at 58.5% (95% CI, 42.1-73.7; P < .001)...In conclusion, the CLL2-GIVe regimen is a promising fixed-duration, first-line treatment for patients with high-risk CLL with a manageable safety profile.
DOI:
10.1182/blood.2023020013
Source:
Title:
343 Final Analysis of the Prospective Multicenter CLL2-Give Trial of Obinutuzumab (GA101, G), Ibrutinib (I), and Venetoclax (Ve) in Untreated Patients with CLL with 17p Deletion/TP53 Mutation
Published date:
11/03/2022
Excerpt:
CLL2-GIVe is an open-label, multicenter phase 2 trial including pts with previously untreated CLL with del(17p) and/or TP53 mutation….With a CR rate of 58.5% (24 pts) at final restaging (C15), the primary endpoint was met (95% CI: 42.1-73.7, p<0.001), rate of partial remission (PR) was 41.5% (17 pts).
DOI:
https://doi.org/10.1182/blood-2022-163245
Trial ID:
