Nivolumab With Gemcitabine, Oxaliplatin + Rituximab in r/r Elderly Lymphoma Patients

Sponsor
Universität des Saarlandes
Study ID
NCT03366272
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Lymphoma, Non-Hodgkin

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    eight cycles of nivolumab (240 mg flatdose) plus (R)-GemOx in 2-wk intervals followed by additional 9 infusions of Nivolumab (480 mg flatdose) in 4-wk intervals as consolidation or up to progression or unacceptable toxicity, whatever occurs first
  • Rituximab — DRUG
    eight cycles of R-GemOx in 2-wk intervals
  • Gemcitabine — DRUG
    eight cycles of (R)-GemOx in 2-wk intervals
  • Oxaliplatin — DEVICE
    eight cycles of (R)-GemOx in 2-wk intervals

Study Details

This study evaluates the addition of nivolumab to gemcitabine, oxaliplatin plus rituximab in case of B-cell lymphoma

Key Dates

Start date
Dec 5, 2017
Status verified
Jan 2025
Primary completion
Jan 15, 2025
Completion
Jan 15, 2025

Study Design

Enrollment
348 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: (R)-GemOx
    eight cycles of (R)-GemOx (Gemcitabine 1000 mg/m2, d1, Oxaliplatin 100 mg/m2, d1, Rituximab 375 mg/m2 in case of B-cell lymphoma disease, repeated every 2 wks)
  • Experimental: Nivo-(R)-GemOx
    eight cycles of nivolumab (240 mg flatdose) plus (R)-GemOx in 2-wk intervals followed by additional 9 infusions of Nivolumab (480 mg flatdose) in 4-wk intervals as consolidation or up to progression or unacceptable toxicity, whatever occurs first

Primary Outcome Measure

PFS [ Time Frame: 1 year ]

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