Therapy Detail
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| Therapy Name | Ibrutinib + Rituximab |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Ibrutinib | Imbruvica | PCI-32765 | BTK inhibitor 36 EGFR Inhibitor (Pan) 61 HER2 Inhibitor 41 | Imbruvica (ibrutinib) is a selective, irreversible inhibitor of Bruton's tyrosine kinase (BTK), which promotes apoptosis and inhibits B-cell mediated signaling pathways, and has additional activity against ERBB2 (HER2) and EGFR (PMID: 20615965, PMID: 21422473, PMID: 27678331). Imbruvica (Ibrutinib) is FDA approved for use in patients with mantle cell lymphoma, CLL/SLL and CLL/SLL with del 17p, Waldenstroem’s macroglobulinemia, marginal zone lymphoma, and in combination with Rituxan (rituximab) for untreated CLL/SLL (FDA.gov). |
| 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). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| TP53 G244S | mantle cell lymphoma | predicted - sensitive | Ibrutinib + Rituximab | Case Reports/Case Series | Actionable | In a clinical case study, a patient with non-nodal leukemic mantle cell lymphoma harboring TP53 G244S, as well as KMT2A V2593A and BCOR S830Cfs*6, achieved complete remission (CR) with no evident minimum residual disease after 5 months of combined Rituxan (rituximab) and Imbruvica (ibrutinib) therapy, and following subsequent autologous stem-cell transplantation remained in CR beyond 18 months (PMID: 30559058). | 30559058 |
| TP53 loss | mantle cell lymphoma | predicted - sensitive | Ibrutinib + Rituximab | Case Reports/Case Series | Actionable | In a clinical case study, a patient with non-nodal leukemic mantle cell lymphoma with TP53 loss, as well as a CCND1 translocation, had a rapid response to combined Rituxan (rituximab) and Imbruvica (ibrutinib) therapy, achieved a complete remission (CR) within 6 months, underwent autologous stem-cell transplantation, and remained in CR 18 months thereafter (PMID: 30559058). | 30559058 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05564052 | Phase II | Ibrutinib + Rituximab Bortezomib + Lenalidomide + Rituximab | A Study of Ibrutinib With Rituximab in Relapsed/Refractory Mantle Cell Lymphoma (VEGA) | Active, not recruiting | ESP | 12 |
| NCT04840602 | Phase II | Ibrutinib + Rituximab + Venetoclax Ibrutinib + Rituximab | Testing the Addition of a New Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Rituximab) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma | Recruiting | USA | 0 |
| NCT04212013 | Phase III | Ibrutinib Ibrutinib + Rituximab | A Study of Ibrutinib With Rituximab in People With Untreated Marginal Zone Lymphoma | Active, not recruiting | USA | 0 |
| NCT02947347 | Phase III | Ibrutinib Ibrutinib + Rituximab | Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | CAN | BEL | AUT | AUS | 9 |
| NCT04061512 | Phase II | Cyclophosphamide + Dexamethasone + Rituximab Ibrutinib + Rituximab | Rituximab and Ibrutinib (RI) Versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as Initial Therapy for Waldenström's Macroglobulinaemia (RAINBOW) | Recruiting | GBR | 0 |
| NCT02007044 | Phase II | Ibrutinib Ibrutinib + Rituximab | Ibrutinib With or Without Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia | Active, not recruiting | USA | 0 |
| NCT01880567 | Phase II | Ibrutinib + Rituximab | Ibrutinib and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or Older Patients With Newly Diagnosed Mantle Cell Lymphoma | Active, not recruiting | USA | 0 |
| NCT03697512 | Phase II | Ibrutinib + Rituximab | MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas (MALIBU) | Active, not recruiting | ITA | FRA | BEL | 2 |
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