Therapy Detail

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Therapy Name Acalabrutinib + Bendamustine + Rituximab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Acalabrutinib Calquence ACP-196 BTK inhibitor 38 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, and in combination with Treanda (bendamustine) and Rituxan (rituximab) in patients with untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation (FDA.gov).
Bendamustine Treanda Ribomustin|SyB L-0501|SDX-105 Chemotherapy - Alkylating 18 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 25 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).

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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
NCT04624906 Phase II Acalabrutinib + Bendamustine + Rituximab Bendamustine, Rituximab and Acalabrutinib in Waldenstrom's Macroglobulinemia (BRAWM) Active, not recruiting CAN 0
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 Active, not 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 | POL | ITA 0
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 Active, not recruiting USA | ROU | POL | NZL | ITA | ISR | HUN | GRC | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUS | ARG 10


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