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|Therapy Name||Ibrutinib + Rituximab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Ibrutinib||Imbruvica||PCI-32765||BTK inhibitor 25 EGFR Inhibitor (Pan) 46 HER2 Inhibitor 26||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 12||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, and in combination with fludarabine and cyclophosphamide in CD20-positive chronic lymphocytic leukemia (FDA.gov).|
|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|
|Unknown unknown||CLL/SLL||not applicable||Ibrutinib + Rituximab||FDA approved||Actionable||In a Phase III trial that supported FDA approval, combination of Imbruvica (ibrutinib) and Rituxan (rituximab) resulted in superior progression-free survival at 3 years (89.4% vs 72.9%, HR=0.35, p<0.001) and overall survival at 3 years (98.8% vs 91.5%, HR=0.17, p<0.001) compared to chemoimmunotherapy in patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (PMID: 31365801; NCT02048813).||detail... 31365801|
|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|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|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|
|NCT04212013||Phase III||Ibrutinib Ibrutinib + Rituximab||A Study of Ibrutinib With Rituximab in People With Untreated Marginal Zone Lymphoma||Recruiting||USA||0|
|NCT02947347||Phase III||Ibrutinib Ibrutinib + Rituximab||Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma||Recruiting||USA | CAN||18|