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

U

Universität des Saarlandes

Status and phase

Active, not recruiting
Phase 3
Phase 2

Conditions

Lymphoma, Non-Hodgkin

Treatments

Drug: Gemcitabine
Drug: Rituximab
Device: Oxaliplatin
Drug: Nivolumab

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03366272
DSHNHL 2015-1

Details and patient eligibility

About

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

Full description

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

Enrollment

348 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients with first relapse or progression of an aggressive Non-Hodgkin's lymphoma
  • all patient >65 years of age or > 18 years if not eligible for neither autologous nor allogeneic stem cell transplantation
  • 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 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
  • HIV-infection
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

348 participants in 2 patient groups

(R)-GemOx
Active Comparator group
Description:
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)
Treatment:
Device: Oxaliplatin
Drug: Rituximab
Drug: Gemcitabine
Nivo-(R)-GemOx
Experimental group
Description:
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
Treatment:
Drug: Nivolumab
Device: Oxaliplatin
Drug: Rituximab
Drug: Gemcitabine

Trial contacts and locations

77

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Data sourced from clinicaltrials.gov

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