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Association details:
| Biomarker: | TP53 mutation |
|---|---|
| Cancer: | Chronic Lymphocytic Leukemia |
| Drug: | Venclexta (venetoclax) (Bcl2 inhibitor) + Gazyva (obinutuzumab) (CD20 inhibitor) + Calquence (acalabrutinib) (BTK inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Comparison of a fixed-duration treatment of acalabrutinib, venetoclax and obinutuzumab to a treatment of venetoclax and obinutuzumab in patients with high risk chronic lymphocytic leukemia Vergleich einer befristeten Therapie mit Acalabrutinib, Venetoclax und Obinutuzumab mit der Therapie von Venetoclax und Obinutuzumab bei Patienten mit chronischer lymphytischer Leukämie mit hohem Risiko
Excerpt:
...At least one of the following risk factors: 17p- deletion, TP53 mutation, complex karyo-type (defined as defined as the presence of 3 or more chromosomal aberrations in 2 or more metaphases.4. ...
Trial ID:
Source:
Title:
Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Excerpt:
...Cohort 1: Untreated patients with at least 1 high-risk feature (del(17p) or mutated TP53 or del(11q) or unmutated IGHV or complex karyotype) OR ≥65 years of age Cohort 2: Relapsed after and/or refractory to at least one prior therapy 2....
Trial ID:
More C2 evidence
Source:
Title:
A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL
Excerpt:
...17p-deletion, TP53-mutation or complex karyotype (defined as defined as the presence of 3 or more chromosomal aberrations in 2 or more metaphases.)....
Trial ID:
Source:
Title:
Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL
Excerpt:
...- TP53 mutation...
Trial ID:
Less C2 evidence
Source:
Title:
344 Updated Results from a Multicenter, Phase 2 Study of Acalabrutinib, Venetoclax, Obinutuzumab (AVO) in a Population of Previously Untreated Patients with CLL Enriched for High-Risk Disease
Published date:
11/03/2022
Excerpt:
In the 29 pts with TP53-aberrant disease evaluable at C16D1, the best ORR is 100% (52% CR, 48% PR)...AVO is a highly active, well-tolerated triplet in a frontline CLL population enriched for high-risk disease, with 83% of TP53-aberrant pts achieving BM-uMRD after 15 mos of tx.
DOI:
https://doi.org/10.1182/blood-2022-168003
Trial ID:
Test:
Source:
Title:
Updated Safety and Efficacy Results from a Phase 2 Study of Acalabrutinib, Venetoclax and Obinutuzumab (AVO) for Frontline Treatment of Chronic Lymphocytic Leukemia (CLL)
Published date:
11/04/2020
Excerpt:
In the 10 pts with TP53-aberrant disease who have reached C16 to date, 4 had CR and 6 had PR, with 9/10 pts PB-uMRD and 7/10 pts BM-uMRD….The AVO triplet is highly active, with 78% achieving BM-uMRD after 15 months of time-limited therapy in a frontline CLL population that included nearly 40% pts with TP53 aberrant disease.
Trial ID:
