Therapy Detail
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| Therapy Name | Rituximab + Venetoclax |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Rituximab | Rituxan | IDEC-C2B8|MabThera | CD20 Antibody 21 | Rituxan (rituximab) is a chimeric mononclonal antibody that binds to CD20 on B-cells, resulting in induction of complement-dependent and antibody-dependent cytotoxicity, and potentially leading to decreased B-cell tumor growth (PMID: 28983798). Rituxan (rituximab) is FDA approved for use as monotherapy or in combination with chemotherapy in CD20-positive B-cell non-Hodgkin lymphoma, in combination with fludarabine and cyclophosphamide in CD20-positive chronic lymphocytic leukemia, and in combination with chemotherapy in pediatric patients (6 month to 18 years of age) with treatment-naive, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia (B-AL) (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 |
|---|---|---|---|---|---|---|---|
| TP53 loss | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Rituximab + Venetoclax | Guideline | Actionable | Venclexta (venetoclax) combined with Rituxan (rituximab) is indicated in the guidelines as second line and subsequent therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with TP53 loss (NCCN.org). | detail... |
| TP53 mutant | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Rituximab + Venetoclax | Guideline | Actionable | Venclexta (venetoclax) combined with Rituxan (rituximab) is indicated in the guidelines as second line and subsequent therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with a TP53 mutation (NCCN.org). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04758975 | Phase II | Rituximab + Venetoclax Ibrutinib + Rituximab + Venetoclax | Venetoclax, Rituximab and Ibrutinib in TN Patients With CLL Undetectable Minimal Residual Disease (uMRD) in Treatment-naïve Patients With Chronic Lymphocytic Leukemia (CLL) (VALUABLE) | Recruiting | ITA | 0 |
| NCT04965493 | Phase III | Rituximab + Venetoclax Pirtobrutinib + Rituximab + Venetoclax | A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (BRUIN CLL-322) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 13 |
| NCT05025423 | Phase II | Rituximab + Venetoclax | Phase II Trial of Venetoclax and Rituximab as Initial Therapy in Older Patients With Mantle Cell Lymphoma | Recruiting | USA | 0 |
| NCT03467867 | Phase II | Hyaluronidase + Rituximab + Venetoclax Rituximab + Venetoclax | A Study of Venetoclax and Rituximab/Hyaluronidase Human in Relapsed/Refractory CLL | Active, not recruiting | USA | 0 |
| NCT02187861 | Phase II | Bendamustine + Rituximab Bendamustine + Rituximab + Venetoclax Rituximab + Venetoclax | A Study Evaluating the Safety and Efficacy of GDC-0199 (ABT-199) Plus Bendamustine + Rituximab (BR) in Comparison With BR or GDC-0199 Plus Rituximab in Patients With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma | Completed | USA | ITA | GBR | FRA | DEU | CAN | BEL | AUS | 0 |
| NCT05947851 | Phase III | Rituximab + Venetoclax ARQ 531 + Venetoclax | A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 7 |
| NCT04416451 | Phase II | Rituximab + Venetoclax | Study of Rituximab and Venetoclax in People With Newly Diagnosed Marginal Zone Lymphoma | Active, not recruiting | USA | 0 |
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