Therapy Detail

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Therapy Name Acalabrutinib + Obinutuzumab + Venetoclax
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Acalabrutinib Calquence ACP-196 BTK inhibitor 37 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).
Obinutuzumab Gazyva R7159|afutuzumab|GA101|GA-101|RO 5072759 CD20 Antibody 24 Gazyva (obinutuzumab) is a glycoengineered anti-CD20 antibody that binds to CD20 on B-cells, resulting in increased antibody-dependent cellular cytotoxicity and induction of apoptosis, and potentially leading to decreased growth of B-cell tumors (PMID: 20194898, PMID: 21220500). Gazyva (obinutuzumab) is FDA approved in combination with Ambochlorin (chlorambucil) for chronic lymphocytic leukemia and in combination with Treanda (bendamustine) or chemotherapy for follicular lymphoma (FDA.gov).
Venetoclax Venclexta ABT-199|RG7601|GDC-0199|ABT119|Venclyxto BCL2 inhibitor 27 Venclexta (venetoclax) is a BH3-mimetic that binds to and inhibits BCL2, resulting in increased tumor cell apoptosis (PMID: 26589495, PMID: 25048785). Venclexta (venetoclax) is FDA approved for use in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and in combination with chemotherapy in patients 75 years old or older with newly-diagnosed acute myeloid leukemia (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
NCT03836261 Phase III Bendamustine + Rituximab Cyclophosphamide + Fludarabine + Rituximab Acalabrutinib + Venetoclax Acalabrutinib + Obinutuzumab + Venetoclax Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL (AMPLIFY) Active, not recruiting USA | TUR | SWE | SVK | POL | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | BGR | AUT | AUS | ARG 6
NCT03580928 Phase II Acalabrutinib + Obinutuzumab + Venetoclax Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL (AVO) Active, not recruiting USA 0
NCT04169737 Phase II Acalabrutinib + Obinutuzumab + Venetoclax Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Recruiting USA 0
NCT04855695 Phase Ib/II Acalabrutinib + Obinutuzumab + Venetoclax Avo In R/R And Previously Untreated MCL Recruiting USA 0
NCT05197192 Phase III Obinutuzumab + Venetoclax Acalabrutinib + Obinutuzumab + Venetoclax A Prospective, Open-label, Multicentre, Randomized, Phase-3-trial of Acalabrutinib, Obinutuzumab and Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk Chronic Lymphatic Leukemia Recruiting DEU 0


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