Therapy Detail
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| Therapy Name | Acalabrutinib + Obinutuzumab |
| 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). |
| Obinutuzumab | Gazyva | R7159|afutuzumab|GA101|GA-101|RO 5072759 | CD20 Antibody 25 | 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). |
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| 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... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
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