A Phase I/II first-line study of R-CHOP plus B-cell receptor/NF-κB-double-targeting to molecularly assess therapy response

Item Type: | Article |
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Title: | A Phase I/II first-line study of R-CHOP plus B-cell receptor/NF-κB-double-targeting to molecularly assess therapy response |
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Creators Name: | Denker, S. and Bittner, A. and Na, I.K. and Kase, J. and Frick, M. and Anagnostopoulos, I. and Hummel, M. and Schmitt, C.A. |
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Abstract: | The ImbruVeRCHOP trial is an investigator-initiated, multicenter, single-arm, open label Phase I/II study for patients 61-80 years of age with newly diagnosed CD20(+) diffuse large B-cell lymphoma and a higher risk profile (International Prognostic Index ≥2). Patients receive standard chemotherapy (CHOP) plus immunotherapy (Rituximab), a biological agent (the proteasome inhibitor Bortezomib) and a signaling inhibitor (the Bruton's Tyrosine Kinase-targeting therapeutic Ibrutinib). Using an all-comers approach, but subjecting patients to another lymphoma biopsy acutely under first-cycle immune-chemo drug exposure, ImbruVeRCHOP seeks to identify an unbiased molecular responder signature that marks diffuse large B-cell lymphoma patients at risk and likely to benefit from this regimen as a double, proximal and distal B-cell receptor/NF-κB-co-targeting extension of the current R-CHOP standard of care. EudraCT-Number: 2015-003429-32; ClinicalTrials.gov identifier: NCT03129828. |
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Keywords: | Biomarkers, Bortezomib, Chemotherapy, CHOP, Diffuse Large B-Cell Lymphoma, Ibrutinib, Non-Hodgkin Lymphoma, Novel Study Design, Prediction, Rituximab, Targeted Therapy |
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Source: | International Journal of Hematologic Oncology |
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ISSN: | 2045-1393 |
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Publisher: | Future Medicine |
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Volume: | 8 |
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Number: | 4 |
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Page Range: | IJH20 |
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Date: | 19 December 2019 |
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Official Publication: | https://doi.org/10.2217/ijh-2019-0010 |
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PubMed: | View item in PubMed |
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