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|Therapy Name||Acalabrutinib + Bendamustine + Rituximab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Acalabrutinib||Calquence||ACP-196||BTK inhibitor 28||Calquence (acalabrutinib) selectively inhibits BTK, resulting in decreased B-cell receptor signaling, and potentially leading to decreased tumor cell proliferation (PMID: 27903679, PMID: 26957112). Calquence (acalabrutinib) is FDA approved for use in patients with mantle cell lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma (FDA.gov).|
|Bendamustine||Treanda||Ribomustin|SyB L-0501|SDX-105||Chemotherapy - Alkylating 16||Treanda (bendamustine) is an alkylating agent with unique mechanisms, resulting in increased DNA damage and base-excision DNA repair pathway induction, and potentially leading to decreased growth of tumors, including those resistant to other alkylating agents (PMID: 18172283, PMID: 19117340, PMID: 19224851). Treanda (bendamustine) is FDA approved for use in chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma (FDA.gov).|
|Rituximab||Rituxan||IDEC-C2B8|MabThera||CD20 Antibody 14||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).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT02972840||Phase III||Bendamustine + Rituximab Acalabrutinib + Bendamustine + Rituximab||A Study of Bendamustine and Rituximab Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated Mantle Cell Lymphoma||Recruiting||USA | ITA | FRA | ESP | DEU | CAN | BEL||20|
|NCT04115631||Phase II||Acalabrutinib + Bendamustine + Rituximab Bendamustine + Cytarabine + Rituximab Acalabrutinib + Bendamustine + Cytarabine + Rituximab||A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma||Recruiting||USA||0|
|NCT02717624||Phase I||Acalabrutinib + Bendamustine + Rituximab||A Study of ACP-196 in Combination With Bendamustine and Rituximab in Subjects With Mantle Cell Lymphoma||Active, not recruiting||USA | ITA||1|
|NCT04624906||Phase II||Acalabrutinib + Bendamustine + Rituximab||Bendamustine, Rituximab and Acalabrutinib in Waldenstrom's Macroglobulinemia (BRAWM)||Recruiting||CAN||0|