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 26 | 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 29 | 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 mutant | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Rituximab + Venetoclax | Guideline | Actionable | Venclexta (venetoclax) combined with Rituxan (rituximab) is included in guidelines as second-line or subsequent therapy (category 1) for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with a TP53 mutation (NCCN.org). | detail... |
| TP53 loss | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Rituximab + Venetoclax | Guideline | Actionable | Venclexta (venetoclax) combined with Rituxan (rituximab) is included in guidelines as second-line or subsequent 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 |
|---|---|---|---|---|---|---|
| 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 |
| NCT06846671 | Phase III | BGB-16673 Idelalisib + Rituximab Bendamustine + Rituximab Rituximab + Venetoclax | A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors (CaDAnCe-302) | Recruiting | USA | TUR | POL | ITA | GBR | DEU | CZE | BRA | AUS | ARG | 2 |
| NCT06510309 | Phase II | Rituximab + Venetoclax | A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma | Not yet recruiting | USA | 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) | Active, not recruiting | USA | SWE | POL | NOR | ITA | ISR | IRL | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BEL | AUS | 5 |
| NCT05099471 | Phase II | Cyclophosphamide + Dexamethasone + Rituximab Rituximab + Venetoclax | Efficacy of Venetoclax in Combination With Rituximab in Waldenström's Macroglobulinemia (VIWA-1) | Recruiting | GRC | DEU | 0 |
| NCT05025423 | Phase II | Rituximab + Venetoclax | Phase II Trial of Venetoclax and Rituximab as Initial Therapy in Older Patients With Mantle Cell Lymphoma | Terminated | USA | 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 | TUR | ITA | ISR | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | ARG | 5 |
| 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 |
| NCT06644183 | Phase Ib/II | Rituximab + Venetoclax Rituximab + Roginolisib + Venetoclax | Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL) | 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 |
| NCT06943872 | Phase III | BGB-11417 + Obinutuzumab BGB-11417 + Rituximab Rituximab + Venetoclax | A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL) | Recruiting | USA | NZL | NLD | ITA | FRA | ESP | DEU | BRA | AUT | AUS | 1 |
| 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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