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Association details:
| Biomarker: | TP53 mutation |
|---|---|
| Cancer: | Chronic Lymphocytic Leukemia |
| Drug: | Venclexta (venetoclax) (Bcl2 inhibitor) + Rituxan (rituximab) (CD20 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma:…CLL/SLL with del(17p)/TP53 mutation…Preferred regimens...Venetoclax + rituximab
Source:
Title:
First Prospective Data on Impact of Minimal Residual Disease on Long-Term Clinical Outcomes after Venetoclax Plus Rituximab Versus Bendamustine Plus Rituximab: Phase III MURANO Study
Published date:
11/01/2018
Excerpt:
MURANO demonstrated significant PFS benefit for venetoclax + rituximab (VenR) given for a fixed duration vs bendamustine + rituximab (BR) in relapsed/refractory (R/R) CLL. Here we present analysis of peripheral blood (PB) MRD kinetics in relation to PFS in MURANO with long follow up, when all pts have completed therapy. VenR pts achieved high PB uMRD rates...Consistently high uMRD rates were observed in all VenR subgroups, including pts with high-risk cytogenetics and molecular factors: del(17p) and/or TP53 mutated…
DOI:
10.1182/blood-2018-99-117050
Trial ID:
Source:
Title:
IMPACT OF TP53-MUTATED CLONE SIZE ON OUTCOME OF RELAPSED/REFRACTORY (R/R) CLL PATIENTS TREATED WITH VENETOCLAX PLUS RITUXIMAB WITHIN THE PHASE 3 MURANO STUDY
Published date:
05/17/2018
Excerpt:
Patients with both del(17p) and TP53 mutations, indicative of loss of TP53 on both alleles, had inferior outcomes to pts with either del(17p) or TP53 mutation alone, with BR. Importantly, PFS was superior for VenR vs BR across subgroups with del(17p) and/or TP53 mutations including high and low clone size.
Trial ID:
Source:
Title:
Activity and Safety of Front-line Venetoclax and Rituximab in Young and Fit Patients With Chronic Lymphocytic Leukemia
Excerpt:
...Tasso di CR alla fine del trattamento (mese 15) compreso l'aumento del venetoclax, 6 cicli mensili di venetoclax e di rituximab in combinazione (VR), 6 cicli mensili di venetoclax somministrato come agente singolo in pazienti idonei con LLC non IGHV mutati e/o TP53 mutati....
Trial ID:
Source:
Title:
Study conducted in several centers to evaluate the ability of a drug called Venetoclax associated with another drug called Rituximab to produce on the human body the desired healing effects and side effects in young patients who are diagnosed with chronic lymphocytic leukemia. Studio condotto in più centri per valutare la capacità di un farmaco denominato Venetoclax associato ad un altro farmaco denominato Rituximab di produrre sull'organismo umano gli effetti curativi desiderati e gli effetti collaterali in pazienti giovani ai quali viene diagnosticata la leucemia linfocitica cronica.
Excerpt:
...Assenza di mutazione IGHV e/o presenza di mutazione TP53.6. ...
Trial ID:
More C2 evidence
Source:
Title:
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010)
Excerpt:
...- Deletion (Del) (17p) status, tumor protein 53 (TP53) mutation status, immunoglobulin heavy chain gene (IGHV) mutation status and Bruton's tyrosine kinase (BTK)-C481 mutation status results required before randomization for Part 2 participants only....
Trial ID:
Less C2 evidence
Source:
Title:
SAFETY AND EFFECTIVENESS IN R/R CLL PATIENTS TREATED WITH VENETOCLAX IN COMBINATION WITH RITUXIMAB UNDER REAL-WORLD CONDITIONS IN AUSTRIA, GERMANY, AND SWITZERLAND
Published date:
06/09/2023
Excerpt:
Adult patients with CLL requiring therapy treated with Ven+R according to local label are eligible for the study….The response rate in patients presenting with high risk features, e.g., del(17p), TP53 mutation or unmutated IGHV, was high.
DOI:
https://doi.org/10.1002/hon.3165_590
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.
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:
https://doi.org/10.1182/blood-2019-121424
Trial ID:
