Therapy Detail
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| Therapy Name | Ofatumumab |
| Synonyms | |
| Therapy Description |
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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| 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). |
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- Use quotes to match a longer phrase which contains spaces "mtor c1483f"
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| Unknown unknown | chronic lymphocytic leukemia | not applicable | Ofatumumab | FDA approved | Actionable | In a Phase III trial supporting FDA approval, Arzerra (ofatumumab) maintenance treatment resulted in improved progression free survival (29.4 vs 15.2 months) compared to observation group in chronic lymphocytic leukemia patients in complete or partial remission after second-line or third-line treatment (PMID: 20194866, PMID: 26377300). | 26377300 20194866 detail... |
| TP53 mutant | CLL/SLL | sensitive | Ofatumumab | Guideline | Actionable | Arzerra (ofatumumab) is indicated in the guidelines as second line and subsequent therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with TP53 mutation (NCCN.org). | detail... |
| TP53 loss | CLL/SLL | sensitive | Ofatumumab | Guideline | Actionable | Arzerra (ofatumumab) is indicated in the guidelines as second line and subsequent therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with TP53 loss (NCCN.org). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02004522 | Phase III | Duvelisib Ofatumumab | A Phase 3 Study of IPI-145 Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO) | Active, not recruiting | USA | 10 |
| NCT02049515 | Phase III | Ofatumumab Duvelisib | A Phase 3 Extension Study of IPI-145 and Ofatumumab in Patients With CLL/SLL Previously Enrolled in Study IPI-145-07 | Completed | USA | 10 |
| NCT03136146 | Phase II | Cyclophosphamide Bortezomib Etoposide Rituximab Ofatumumab Clofarabine Pegfilgrastim | Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) | Recruiting | USA | 0 |
| NCT03488225 | Phase II | Mercaptopurine + Methotrexate + Prednisone + Vincristine Sulfate Cytarabine + Leucovorin + Methotrexate Inotuzumab ozogamicin Ofatumumab Rituximab Cytarabine + Doxorubicin + Methotrexate + Vincristine Sulfate Pegfilgrastim Cyclophosphamide + Dexamethasone + Mesna | Hyper-CVAD in Combination With Inotuzumab Ozogamicin as Frontline Therapy for Adults With Acute Lymphocytic Leukemia | Terminated | USA | 0 |
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