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    Association details:
    Biomarker:TP53 mutation
    Cancer:Chronic Lymphocytic Leukemia
    Drug:Gazyva (obinutuzumab) (CD20 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: CLL/SLL With del(17p)/TP53 Mutation...Useful in Certain Circumstances...Obinutuzumab…
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    SOHO 2021
    Title:

    Acalabrutinib ± Obinutuzumab vs Obinutuzumab + Chlorambucil in Treatment-Naïve Chronic Lymphocytic Leukemia: ELEVATE-TN 4-Year Followup

    Published date:
    09/01/2021
    Excerpt:
    In patients with del(17p) and/or TP53, median PFS was NR (A+O and A) vs 17.5 months for O+Clb (P<0.0001).
    Secondary therapy:
    chlorambucil
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ICML 2021
    Title:

    030 | GENETIC MARKERS AND OUTCOME WITH FRONT LINE OBINUTUZUMAB PLUS EITHER CHLORAMBUCIL OR VENETOCLAX - UPDATED ANALYSIS OF THE CLL14 TRIAL

    Published date:
    06/09/2021
    Excerpt:
    CONTRADICTED EVIDENCE:...OS was shorter with del(17p) and TP53 mutation in both treatment arms (GClb: HR 5.7 and HR 3.1, VenG: HR 3.5 and HR 3.0, all p < 0.01) and with mutated SF3B1 (HR 2.0, p = 0.05)…
    Secondary therapy:
    chlorambucil
    DOI:
    https://doi.org/10.1002/hon.2879
    Trial ID:
    CLL14 study
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    EHA 2021
    Title:

    GENETIC MARKERS AND OUTCOME IN FRONT LINE OBINUTUZUMAB PLUS CHLORAMBUCIL OR VENETOCLAX - UPDATED ANALYSIS OF THE CLL14 TRIAL

    Published date:
    05/12/2021
    Excerpt:
    CONTRADICTED EVIDENCE:...gene mutations in the CLL14 trial comparing obinutuzumab+chlorambucil (GClb) vs. obinutuzumab+venetoclax (VenG) in 432 patients...Overall survival (OS) was shorter with del(17p) and TP53 mutation in both treatment arms (GClb: HR 5.7 and HR 3.1, VenG: HR 3.5 and HR 3.0, all p<0.01)...
    Secondary therapy:
    chlorambucil
    Trial ID:
    CLL14 study
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia

    Excerpt:
    ...- Participants with 17p-deletion and/or p53 mutation may be included at the investigator's discretion...
    Trial ID:
    NCT01905943
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Obinutuzumab Containing Conditioning Regimen for Patients With Poor Risk CLL or Richter's Transformation Requiring Allogeneic Stem Cell Transplantation

    Excerpt:
    ...- Non-response or early relapse within 24 months after purine analogue combination therapy or treatment of similar efficacy plus high risk CLL TP53 deletion/mutation (del 17p-) and/or del 11 plus response to kinase inhibitors or other small molecules or...
    Trial ID:
    CLLTX1
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    New
    Source:
    Blood
    Title:

    Prognostic and predictive impact of genetic markers in patients with CLL treated with obinutuzumab and venetoclax

    Excerpt:
    ...421 untreated patients within the CLL14 trial (NCT02242942), comparing obinutuzumab+chlorambucil (GClb) vs obinutuzumab+venetoclax (VenG)…. Multivariable analysis identified del(17p), del(11q), unmutated IGHV, and mutated TP53, BIRC3, and SF3B1 as independent prognostic factors for PFS with GClb, whereas for VenG, only del(17p) was significant.
    Secondary therapy:
    chlorambucil
    DOI:
    10.1182/blood.2019004492
    Trial ID:
    CLL14 study