Therapy Detail

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Therapy Name Daratumumab + Ibrutinib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
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 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).

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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
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
NCT03679624 Phase II Daratumumab + Ibrutinib Daratumumab Plus Ibrutinib in Patients With Waldenstrom's Macroglobulinemia Terminated USA 0
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
NCT03447808 Phase I Daratumumab + Ibrutinib Daratumumab and Ibrutinib in Treating Patients With Symptomatic Chronic Lymphocytic Leukemia Active, not recruiting USA 0


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