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Therapy Name | Rituximab + zandelisib |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Rituximab | Rituxan | IDEC-C2B8|MabThera | CD20 Antibody 24 | Rituxan (rituximab) is a chimeric mononclonal antibody that binds to CD20 on B-cells, resulting in induction of complement-dependent and antibody-dependent cytotoxicity, and potentially leading to decreased B-cell tumor growth (PMID: 28983798). Rituxan (rituximab) is FDA approved for use as monotherapy or in combination with chemotherapy in CD20-positive B-cell non-Hodgkin lymphoma, in combination with fludarabine and cyclophosphamide in CD20-positive chronic lymphocytic leukemia, and in combination with chemotherapy in pediatric patients (6 month to 18 years of age) with treatment-naive, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia (B-AL) (FDA.gov). |
zandelisib | ME401|PWT-143|PWT143|ME-401 | PIK3CD inhibitor 27 | Zandelisib (ME-401) is a selective Pi3kd inhibitor that inhibits PI3K/AKT pathway signaling to decrease cell proliferation and induce cell death (PMID: 31506873). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT04745832 | Phase III | Rituximab + zandelisib Bendamustine + Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate | Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL) | Terminated | USA | TUR | POL | NZL | NLD | ITA | HUN | GRC | GBR | FRA | ESP | CAN | BEL | AUS | 5 |
NCT02914938 | Phase I | zandelisib Rituximab + zandelisib | A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma | Terminated | USA | CHE | 0 |