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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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Item Type:Article
Title:A Phase I/II first-line study of R-CHOP plus B-cell receptor/NF-κB-double-targeting to molecularly assess therapy response
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.
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.
Keywords:Biomarkers, Bortezomib, Chemotherapy, CHOP, Diffuse Large B-Cell Lymphoma, Ibrutinib, Non-Hodgkin Lymphoma, Novel Study Design, Prediction, Rituximab, Targeted Therapy
Source:International Journal of Hematologic Oncology
ISSN:2045-1393
Publisher:Future Medicine
Volume:8
Number:4
Page Range:IJH20
Date:19 December 2019
Official Publication:https://doi.org/10.2217/ijh-2019-0010
PubMed:View item in PubMed

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