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

NCT03366272 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2025-01-28

No results posted yet for this study

Summary

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

Conditions

  • Lymphoma, Non-Hodgkin

Interventions

DRUG

Nivolumab

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

DRUG

Rituximab

eight cycles of R-GemOx in 2-wk intervals

DRUG

Gemcitabine

eight cycles of (R)-GemOx in 2-wk intervals

DEVICE

Oxaliplatin

eight cycles of (R)-GemOx in 2-wk intervals

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Lymphoma Study Association

    collaborator OTHER

  • University of Leipzig

    collaborator OTHER

  • Universität des Saarlandes

    lead OTHER

Principal Investigators

  • Gerhard Held, Prof · Universität des Saarlandes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-05
Primary Completion
2025-01-15
Completion
2025-01-15

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Israel
  • Netherlands
  • Poland
  • Portugal

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03366272 on ClinicalTrials.gov