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Therapy Name | Daratumumab + Ibrutinib |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Daratumumab | Darzalex | JNJ-54767414 | CD38 Antibody 20 | Darzalex (Daratumumab) is a human antibody against CD38 that induces antibody-dependent cell-mediated cytotoxicity and complement-mediated cytotoxicity against CD38-positive tumor cells (PMID: 30546360). Darzalex (Daratumumab) is FDA approved for multiple myeloma patients as a monotherapy or in combination with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, or with bortezomib, melphalan, and prednisone, or with pomalidomide and dexamethasone, or with bortezomib, thalidomide and dexamethasone (FDA.gov). |
Ibrutinib | Imbruvica | PCI-32765 | BTK inhibitor 37 EGFR Inhibitor (Pan) 62 HER2 Inhibitor 42 | 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). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT04230304 | Phase II | Daratumumab + Ibrutinib | Daratumumab and Ibrutinib for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia, DIRECT Study | Active, not recruiting | USA | 0 |
NCT03734198 | Phase II | Daratumumab + Ibrutinib | Evaluation of the Safety and Efficacy of the Association of Ibrutinib and Daratumumab in Relapsed/Refractory Chronic Lymphocytic Leukemia With p53 Dysfunction (IDA53) | Active, not recruiting | FRA | 0 |
NCT03447808 | Phase I | Daratumumab + Ibrutinib | Daratumumab and Ibrutinib in Treating Patients With Symptomatic Chronic Lymphocytic Leukemia | Active, not recruiting | USA | 0 |
NCT03679624 | Phase II | Daratumumab + Ibrutinib | Daratumumab Plus Ibrutinib in Patients With Waldenstrom's Macroglobulinemia | Terminated | USA | 0 |