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Ibrutinib + R-CHOP Followed by Ibrutinib Maintenance

NCT03731234 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-12-24

No results posted yet for this study

Summary

This is a prospective, multicenter, single arm, phase II trial in patients with ≥ 18 and \<65 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

Conditions

Interventions

DRUG

Ibrutinib

Ibrutinib in combination to rituximab-CHOP followed by ibrutinib maintenance

Sponsors & Collaborators

  • Janssen-Cilag S.p.A.

    collaborator INDUSTRY

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Maurizio Martelli, Prof. · Dipartimento di Medicina Traslazionale e di Precisione, Università 'La Sapienza'

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-02
Primary Completion
2024-07-30
Completion
2027-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03731234 on ClinicalTrials.gov