Ibrutinib + R-CHOP Followed by Ibrutinib Maintenance

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT03731234
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Ibrutinib in combination to rituximab-CHOP followed by ibrutinib maintenance

Study Details

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

Key Dates

Start date
Jul 2, 2019
Status verified
May 2026
Primary completion
Jul 30, 2024
Completion
Jul 31, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib+R-CHOP
    Screening phase for selection of Activated-B-Cell (ABC)-DLBCL Induction phase: R-CHOP21 x 5 cycles in combination with ibrutinib Maintenance phase: maintenance with Ibrutinib for 18 months for patients responding to the induction phase (CR or PR)

Primary Outcome Measure

Progression-free survival (PFS) (1st time point of assessment) [ Time Frame: Time between the date of enrolment and the date of disease progression, relapse or death from any cause (24 months) ]

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