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|Therapy Name||Chlorambucil + Ofatumumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Ofatumumab||Arzerra||HuMax-CD20||Arzerra (ofatumumab) is a monoclonal antibody that binds to CD20 and induces cytotoxic immune response against CD20 over-expressing cells (PMID: 26855591). Arzerra (ofatumumab) is FDA approved for chronic lymphocytic leukemia (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|NOTCH1 mutant||chronic lymphocytic leukemia||decreased response||Chlorambucil + Ofatumumab||Phase III||Actionable||In a Phase III trial (COMPLEMENT1), the addition of Arzerra (ofatumumab) to Chlorambucil treatment in patients with chronic lymphocytic leukemia was associated with increased benefit to median progression-free survival (mPFS) in patients with wild-type NOTCH1 (mPFS 23.8 mo with ofatumumab vs.13.3 mo without, HR 0.50, CI 95% 0.39-0.63, p<0.01), but did not result in significant mPFS benefit in patients with mutant NOTCH1 (17.2 vs.13.1 mo, HR 0.81, CI 95% 0.50-1.31, p=0.45) (PMID: 31919090; NCT00748189).||31919090|
|Unknown unknown||chronic lymphocytic leukemia||not applicable||Chlorambucil + Ofatumumab||FDA approved||Actionable||In a Phase III trial supporting FDA approval, Arzerra (ofatumumab) and Chlorambucil combination treatment resulted in improved median progression-free survival (22.4 vs. 13.1 months) compared to Chlorambucil alone in treatment-naive patients with chronic lymphocytic leukaemia (PMID: 25882396).||25882396 detail...|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|