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|Therapy Name||Ibrutinib + Rituximab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Ibrutinib||Imbruvica||PCI-32765||BTK inhibitor 35 EGFR Inhibitor (Pan) 60 HER2 Inhibitor 40||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).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|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|
|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|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT04212013||Phase III||Ibrutinib Ibrutinib + Rituximab||A Study of Ibrutinib With Rituximab in People With Untreated Marginal Zone Lymphoma||Active, not recruiting||USA||0|
|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|
|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|
|NCT02007044||Phase II||Ibrutinib Ibrutinib + Rituximab||Ibrutinib With or Without Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia||Active, not recruiting||USA||0|
|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|
|NCT02947347||Phase III||Ibrutinib Ibrutinib + Rituximab||Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma||Active, not recruiting||USA | ITA | GBR | FRA | ESP | CAN | BEL | AUT | AUS||10|
|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|
|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||Suspended||USA||0|