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|Therapy Name||Acalabrutinib + Obinutuzumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Acalabrutinib||Calquence||ACP-196||BTK inhibitor 35||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 21||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).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|TP53 mutant||chronic lymphocytic leukemia/small lymphocytic lymphoma||sensitive||Acalabrutinib + Obinutuzumab||Guideline||Actionable||Calquence (acalabrutinib) combined with Gazyva (obinutuzumab) is indicated in the guidelines as first-line therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with a TP53 mutation (NCCN.org).||detail...|
|TP53 loss||chronic lymphocytic leukemia/small lymphocytic lymphoma||sensitive||Acalabrutinib + Obinutuzumab||Guideline||Actionable||Calquence (acalabrutinib) combined with Gazyva (obinutuzumab) is indicated in the guidelines as first-line therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with TP53 loss (NCCN.org).||detail...|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT03516617||Phase II||Acalabrutinib Acalabrutinib + Obinutuzumab||Acalabrutinib With or Without Obinutuzumab in Treating Participants With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma||Recruiting||USA||0|
|NCT04505254||Phase II||Acalabrutinib + Obinutuzumab||Acalabrutinib and Obinutuzumab for the Treatment of Chronic Lymphocytic Leukemia||Recruiting||USA||0|
|NCT04883437||Phase II||Acalabrutinib + Obinutuzumab||Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas||Recruiting||USA||0|
|NCT02296918||Phase I||Acalabrutinib + Obinutuzumab||ACP-196 in Combination With Obinutuzumab in Relapsed/Refractory or Untreated CLL/SLL/PLL||Active, not recruiting||USA||0|
|NCT05336812||Phase II||Acalabrutinib + Venetoclax Acalabrutinib + Obinutuzumab||Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia||Recruiting||USA||0|
|NCT04722172||Phase II||Acalabrutinib + Obinutuzumab||A Study on Limiting Treatment Time With Acalabrutinib Combined With Obinutuzumab in People With CLL or SLL||Active, not recruiting||USA||0|