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Therapy Name | Acalabrutinib + Obinutuzumab |
Synonyms | |
Therapy Description | |
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). |
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 |
---|---|---|---|---|---|---|
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 |
NCT02296918 | Phase I | Acalabrutinib + Obinutuzumab | ACP-196 in Combination With Obinutuzumab in Relapsed/Refractory or Untreated CLL/SLL/PLL | Active, not recruiting | USA | 0 |
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 |
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 |
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 |
NCT04505254 | Phase II | Acalabrutinib + Obinutuzumab | Acalabrutinib and Obinutuzumab for the Treatment of Chronic Lymphocytic Leukemia | Recruiting | USA | 0 |