Therapy Detail
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| Therapy Name | Chlorambucil + Ofatumumab |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Chlorambucil | Ambochlorin | Chlocambucil | ||
| 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). |
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| 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... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|
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