Ibrutinib + R-CHOP Followed by Ibrutinib Maintenance

  • End date
    Feb 24, 2025
  • participants needed
  • sponsor
    Fondazione Italiana Linfomi ONLUS
Updated on 24 May 2021
Maurizio Martelli, MD
Primary Contact
Casa Sollievo della Sofferenza - UO Ematologia (0.0 mi away) Contact
+49 other location
platelet count
measurable disease
growth factor
gilbert's syndrome
neutrophil count


This is a prospective, multicenter, single arm, phase II trial in patients with 18 and <80 years with poor-prognosis (IPI 2) and newly diagnosed ABC-DLBCL.

Aim of the study is to assess the efficacy and the safety of R-CHOP in combination with ibrutinib for 6 cycles followed by ibrutinib maintenance for 18 months in ABC-DLBCL patients achieving at least a PR after the induction phase


Step 1 - Screening phase If central review will confirm and define the diagnosis of ABC-DLBCL according the COO, eligible patients will have to sign an additional informed consent prior to receive the study subsequent treatment.

Step 2 - study treatment phases Induction phase: 5 courses of R-CHOP every 21 days combined with ibrutinib (560 mg/day, continuously).

Maintenance phase: patients achieving a CR or a PR after 5 courses of RI-CHOP21 will enter the maintenance phase with ibrutinib (560 mg/day, continuously) for 18 months.

Radiotherapy could be delivered as consolidation treatment at the end of R-chemotherapy, according to Institution local clinical practice, in patients with focal PET positive residual disease and to bone extranodal lesions or scrotum, if testicular involvement irrespective of initial tumor diameter.

Condition Diffuse Large B-Cell Lymphoma, diffuse large cell lymphoma, diffuse large b cell lymphoma
Treatment Ibrutinib
Clinical Study IdentifierNCT03731234
SponsorFondazione Italiana Linfomi ONLUS
Last Modified on24 May 2021


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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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