Phase II Study About Combination CHOP-21, Obinutuzumab and Ibrutinib in Untreated Young High Risk DLBCL Patients.

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT02670317
Phase
PHASE2
Status
Terminated

Conditions

  • Lymphoma, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Obinutuzumab — DRUG
    Patients will receive a maximum of 6 courses of G-CHOP-21 followed by 2 doses of Obinutuzumab in combination with Ibrutinib.
  • Ibrutinib — DRUG
    Patients will receive a maximum of 6 courses of G-CHOP-21 followed by 2 doses of Obinutuzumab in combination with Ibrutinib.
  • CHOP — DRUG
    Patients will receive a maximum of 6 courses of CHOP-21 in combination with Obinutuzumab (G) followed by 2 doses of Obinutuzumab in combination with Ibrutinib.

Study Details

This is a prospective, multicenter, single arm, phase II trial in young patients (18-60 years) with poor-prognosis (aaIPI 2 or 3) newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL). Aim of the study is to assess the efficacy and the safety of G-CHOP in combination with ibrutinib.

Key Dates

Start date
Sep 30, 2016
Status verified
Mar 2017
Primary completion
Feb 28, 2017
Completion
Feb 28, 2017

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: G CHOP 21 + Ibrutinib
    Patients will receive a maximum of 6 courses of G-CHOP-21 followed by 2 doses of Obinutuzumab in combination with Ibrutinib.

Primary Outcome Measure

The efficacy of G-CHOP-21 in combination with Ibrutinib in terms of 2-yrs PFS (progression-free survival) [ Time Frame: 2 years ]

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