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

  • End date
    Nov 10, 2024
  • participants needed
  • sponsor
    Universität des Saarlandes
Updated on 31 January 2022
hodgkin's disease
cell transplantation
b-cell lymphoma
aggressive non-hodgkin's lymphoma


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


International, multicentre, randomised, open-label, treatment optimisation study, preceded by safety run-in phases conducted for B-cell and T-cell lymphoma separately.

Condition Lymphoma, Non-Hodgkin
Treatment Rituximab, Gemcitabine, Oxaliplatin, Nivolumab
Clinical Study IdentifierNCT03366272
SponsorUniversität des Saarlandes
Last Modified on31 January 2022


Yes No Not Sure

Inclusion Criteria

patients with first relapse or progression of an aggressive Non-Hodgkin's lymphoma
all patient >65 years of age or older than 18 years if HCT-CI score > 2 or patients who underwent prior autologous stem cell transplantation and are not eligible for allogeneic stem cell Transplantation
all patient >65 years of age or > 18 years if not eligible for neither autologous nor allogeneic stem cell transplantation
All risk groups (IPI 0 to 5)
Diagnosis of aggressive Non-Hodgkin's lymphoma, based on an excisional biopsy of a lymph node or on an appropriate sample of a lymph node or of an extranodal involvement at initial diagnosis or relapse or Progression. The entities treated in the study will be based on the WHO 2017 classification
ECOG 0 - 2
only one prior chemotherapy regimen including an anthracycline. The last cytotoxic drug must be given at least four weeks before entering the study. Rituximab must be part of the first-line regimen in case of B-cell lymphoma (except for primary CD20- negative lymphoma). Patients may have received prior radiation therapy as part of their first-line therapy
Men who are sexually active with women of childbearing potential (WOCBP) must not father a child during and up to 6 months after GemOx and up to 12 months after Rituximab and/or Nivolumab. They are advised to do cryoconservation of sperm prior to treatment
Written informed consent of the patient
Patient must be covered by social security system

Exclusion Criteria

Already initiated lymphoma therapy after first relapse or progression
Serious accompanying disorder or impaired organ function
WBC < 2.5 G/l, Neutrophils < 2 G/l, Platelets < 100 G/l
Prolongation of QTc interval > 450 ms, demonstrated in one electrocardiogram (done as triplicate). This does not apply for patients with a block of the right and/or left bundle branch
Family history for Long QT-Syndrome
active, known or suspected autoimmune disease
no requirement for immunosuppressive doses of systemic corticosteroids
Chronic active hepatitis B or C
Patients with a severe immunodeficiency
Previous therapy with Nivolumab,Gemcitabine or Oxaliplatin
Patients with a "currently active" second malignancy other than non-melanoma skin cancer
CNS involvement of lymphoma
Persistent neuropathy grade >2
Pregnancy or breast-feeding women
Women of childbearing potential
Active serious infections not controlled by oral and/or intravenous antibiotics or anti-fungal medication
Any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities
Lymphomas other than those listed in the inclusion criteria notably indolent lymphoma, Mantle cell lymphoma, Burkitt lymphoma, adult T-cell leukemia/lymphoma
Persons not able to understand the impact, nature, risks and consequences of the trial (including language barrier)
Persons not agreeing to the transmission of their pseudonymous data
Persons depending on sponsor or investigator
Persons from highly protected Groups
Allergies and Adverse Drug Reaction History to study drug components
Participation in another clinical trial with drug intervention within 4 weeks prior to start of the first cycle and during the study. However, participation in a clinical trial of firstline therapy of lymphoma is allowed
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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