A Phase I/II first-line study of R-CHOP plus B-cell receptor/NF-κB-double-targeting to molecularly assess therapy response.
Sophy DenkerAitomi BittnerIl-Kang NaJulia KaseMareike FrickIoannis AnagnostopoulosMichael HummelClemens A SchmittPublished in: International journal of hematologic oncology (2019)
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.
Keyphrases
- diffuse large b cell lymphoma
- newly diagnosed
- end stage renal disease
- ejection fraction
- tyrosine kinase
- chronic kidney disease
- peritoneal dialysis
- epstein barr virus
- prognostic factors
- palliative care
- signaling pathway
- clinical trial
- randomized controlled trial
- emergency department
- chronic pain
- squamous cell carcinoma
- photodynamic therapy
- cell proliferation
- immune response
- toll like receptor
- drug delivery
- radiation therapy
- phase iii
- smoking cessation
- multiple myeloma
- patient reported
- combination therapy