Therapy Detail
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| Therapy Name | Acalabrutinib + 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). |
| 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 |
| NCT06428019 | Phase III | Obinutuzumab + Venetoclax Acalabrutinib + Venetoclax | A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL) | Recruiting | USA | 1 |
| NCT06524375 | Phase II | Acalabrutinib + Venetoclax Ibrutinib + Venetoclax Venetoclax + Zanubrutinib | A Study to Evaluate the Effect of Venetoclax on Participants Receiving a Covalent Bruton's Tyrosine Kinase Inhibitor (cBTKi) for First-Line Chronic Lymphocytic Leukemia (1L CLL) to Achieve Deep Durable Remissions to Allow Off-Treatment Period (BRAVE) | Recruiting | USA | 0 |
| NCT03128879 | Phase II | Acalabrutinib + Venetoclax Ibrutinib + Venetoclax | Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL | Recruiting | USA | 0 |
| NCT06520098 | Phase II | Ibrutinib Zanubrutinib Ibrutinib + Venetoclax Venetoclax + Zanubrutinib Acalabrutinib Acalabrutinib + Venetoclax | A Randomized Phase II Study Of Bruton Tyrosine Kinase Inhibitor With Or Without Venetoclax In Veterans With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (Benefit VA) | Not yet recruiting | USA | 0 |
| NCT04941716 | Phase II | Acalabrutinib + Venetoclax | Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | Recruiting | USA | 0 |
| NCT03946878 | Phase II | Acalabrutinib + Venetoclax | Venetoclax and Acalabrutinib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma | Active, not recruiting | USA | 0 |
| NCT05057494 | Phase III | Obinutuzumab + Venetoclax Acalabrutinib + Venetoclax | A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (MAJIC) | Active, not recruiting | USA | POL | HUN | FRA | ESP | CZE | AUS | 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 |
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