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Association details:
| Biomarker: | TP53 mutation |
|---|---|
| Cancer: | Chronic Lymphocytic Leukemia |
| Drug: | Arzerra (ofatumumab) (CD20 inhibitor) |
| Direction: | Resistant |
Evidence:
Source:
Title:
Prognostic and predictive role of gene mutations in chronic lymphocytic leukemia: results from the pivotal phase III study COMPLEMENT1
Published date:
01/09/2020
Excerpt:
The aim of this study was to evaluate the prognostic value of recurrent molecular abnormalities in patients with CLL...Therefore, we assessed their incidences and associations with other clinical and genetic markers in the prospective multicenter COMPLEMENT1 trial (treatment naive patients not eligible for intensive treatment randomized to chlorambucil (CHL) vs. ofatumumab-CHL (O-CHL))…Analyses of both treatment arms separately generally reiterated the results obtained for the total cohort, with mutations in SF3B1 and TP53 being associated with shorter PFS.
Secondary therapy:
chlorambucil
DOI:
10.3324/haematol.2019.229161
Trial ID:
Source:
Title:
Phase II trial of ofatumumab, dexamethasone and lenalidomide for high-risk CLL (NCRI CLL210)
Excerpt:
...o Constitutional symptoms defined as at least 10% unintentional weight loss within the previous 6 months, significant fatigue preventing usual activities, or fever of at least 38°C for at least 2 weeks or night sweats for at least one month in the absence of infection.• High risk CLL/SLL defined by at least one of the following criteria: o TP53 deletion or mutation affecting at least 20% of CLL cells o Resistant (SD/PD) to fludarabine-containing combination therapy o Relapse within 12 months of responding to fludarabine-containing combination therapy• No prior treatment with ofatumumab or lenalidomide • CLL not known to be resistant to glucocorticoids• No more than 3 previous treatment episodes for CLL• WHO performance status 0-2• Aged at least 18 years• Written Informed Consent...
Trial ID:
Source:
Title:
Phase II salvage treatment with Bendamustine, Ofatumumab and MethylPrednisolone (BOMP) in relapsed B-cell chronic lymphocytic leukemia (B-CLL). Traitement de phase II par Bendamustine, Ofatumumab et MethylPrednisolone (BOMP) dans les leucémies lymphoïdes chroniques B (LLC-B) en rechute.
Excerpt:
...- Tolerance and safety of the BOMP regimen according to the CTC criteria - Rate of achievement of a negative minimal residual disease (MRD) at 6 cycles of BOMP - Survival including progression free survival (PFS), event free Survival (EFS), overall Survival (OS) and time to next treatment (TTNT)- Impact of P53 mutation status/function/expression on response and survival...
Trial ID:
More C2 evidence
Source:
Title:
A MultiCenter study with two antitumoral drugs (Bendamustine and Ofatumumab)in patients with refractory or relapsed leukaemia, where lymphocytes expand and accumulate in blood, lymphonodes and bone marrow. Studio da svolgersi in piu` centri, che prevede l`associazione di due farmaci antitumorali (Bendamustina ed Ofatumumab) in pazienti con una leucemia, in cui i linfociti si espandono e si accumulano in sangue, linfonodi e midollo osseo. Tali pazienti non rispondono ad una precedente terapia o la loro malattia si e` ripresentata.
Excerpt:
...Response rate, duration of response, OS and TTNT according to the following biologic features of CLL: IgVH mutational status, FISH abnormalities (6q-; 11q-; +12; 13q-; 17p-), TP53 mutation, CD38 expression, ZAP70 expression. ...
Trial ID:
