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    BIOMARKER:

    Chr del(17)(p13.1)

    over1year
    Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov)
    P2, N=42, Active, not recruiting, Jennifer Woyach | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    TP53 (Tumor protein P53)
    |
    Chr del(11q) • Chr del(17)(p13.1)
    |
    Imbruvica (ibrutinib)
    2years
    Extended Follow up of a Phase 2 Study of Early Intervention with Lenalidomide in Patients with High-Risk Chronic Lymphocytic Leukemia (ASH 2023)
    In this population of pts with CLL with high-risk disease features predictive of need for earlier treatment, LEN resulted in a prolonged time to subsequent therapy, even in cases of LEN discontinuation. The incidence of gr ≥3 INFs and SN were as expected for this population supporting that LEN does not increase risk for these complications.
    Clinical • P2 data
    |
    IGH (Immunoglobulin Heavy Locus)
    |
    Chr del(11q) • Chr del(17)(p13.1)
    |
    lenalidomide
    over2years
    Copy Number Variations and Gene Mutations Identified by Multiplex Ligation-Dependent Probe Amplification in Romanian Chronic Lymphocytic Leukemia Patients. (PubMed, J Pers Med)
    Del(13q) is associated with the longest survival rate, while the shortest survival is found in patients with del(17p). Even if MLPA has constraints, it may be used as the primary routine analysis in patients with CLL.
    Journal
    |
    NOTCH1 (Notch 1) • MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • SF3B1 (Splicing Factor 3b Subunit 1)
    |
    NOTCH1 mutation • Chr del(11q) • MYD88 mutation • SF3B1 mutation • Chr del(17)(p13.1) • TS 12
    over2years
    EPIC: A NON-INTERVENTIONAL, OBSERVATIONAL STUDY OF CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS TREATED WITH FIRST-LINE ACALABRUTINIB THROUGH THE UK EARLY ACCESS PROGRAMME. INTERIM ANALYSIS UP TO 24 MONTHS (EHA 2023)
    The most common treatment received for COVID-19 (for 32% of patients; 6/19) was sotrovimab. This first IA shows an 81.1% (95% CI, 71.3%–92.4%; n=53) acalabrutinib real-world continuation rate at 12 months in treatment-naïve patients with CLL. Future analyses are aiming at including retrospective data from around 40 clinical sites with approximately 350 eligible patients. Chronic lymphocytic leukemia, Real world data
    Clinical • Observational data
    |
    TP53 (Tumor protein P53) • ATM (ATM serine/threonine kinase) • IGH (Immunoglobulin Heavy Locus)
    |
    TP53 mutation • ATM mutation • IGH mutation • Chr del(17)(p13.1)
    |
    Calquence (acalabrutinib)
    over2years
    Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov)
    P2, N=42, Active, not recruiting, Jennifer Woyach | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial primary completion date
    |
    TP53 (Tumor protein P53)
    |
    Chr del(11q) • Chr del(17)(p13.1)
    |
    Imbruvica (ibrutinib)
    3years
    Prognostic Discrimination within a Heterogeneous Population of TP53-Aberrant Myelodysplastic Syndromes and Acute Myeloid Leukemia (ASH 2022)
    Median overall survival (OS) was similar among patients with monoallelic TP53-mutant MDS, multi-hit TP53-mutant MDS, and monoallelic TP53-mutant AML (median OS 440 days vs. 437 days vs. 440 days, respectively) (Panel A)... TP53-aberrant MDS and AML comprise a prognostically heterogeneous group of patients with inferior clinical outcomes, though the highest risk subgroup appears to be AML with multi-hit TP53 status or AML with TP53 VAF > 50%. There is high value in determining the allelic state and hit status at the time of diagnosis to help prognosticate and develop a long-term management plan. Allo-HCT improves median OS, though durable MRD-negative remission is rare.
    Clinical
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • Chr del(17)(p13.1)
    3years
    Obinutuzumab, acalabrutinib, and venetoclax, after an optional debulking with bendamustine in relapsed or refractory chronic lymphocytic leukaemia (CLL2-BAAG): a multicentre, open-label, phase 2 trial. (PubMed, Lancet Haematol)
    With 76% of patients achieving uMRD in peripheral blood, this trial did not reach the prespecified activity threshold. Triple therapy with obinutuzumab, acalabrutinib, and venetoclax after an optional debulking with bendamustine regimen requires further evaluation in larger trials to define its value compared with double treatment with a BTK or BCL2 inhibitor combined with obinutuzumab or a combination of the two oral targeted drugs. Until these trials show a clear benefit, the use of the triple combination in routine practice cannot be recommended.
    P2 data • Clinical Trial,Phase II • Journal • IO biomarker
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • Chr del(17)(p13.1)
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • Calquence (acalabrutinib) • bendamustine
    over3years
    A041702: Testing The Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P3; Suspended --> Active, not recruiting
    Enrollment closed
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
    |
    Chr t(11;14) • Chr del(17)(p13.1)
    |
    clonoSEQ
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Gazyva (obinutuzumab)
    over3years
    A041702: Testing The Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia (clinicaltrials.gov)
    P3; Recruiting --> Suspended
    Trial suspension
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
    |
    Chr t(11;14) • Chr del(17)(p13.1)
    |
    clonoSEQ
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • Gazyva (obinutuzumab)
    almost4years
    Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov)
    P2, N=42, Active, not recruiting, Jennifer Woyach | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2022
    Trial completion date • Trial primary completion date
    |
    TP53 (Tumor protein P53)
    |
    Chr del(11q) • Chr del(17)(p13.1)
    |
    Imbruvica (ibrutinib)