Status:
COMPLETED
Nivolumab With Gemcitabine, Oxaliplatin + Rituximab in r/r Elderly Lymphoma Patients
Lead Sponsor:
Universität des Saarlandes
Collaborating Sponsors:
Bristol-Myers Squibb
Lymphoma Study Association
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study evaluates the addition of nivolumab to gemcitabine, oxaliplatin plus rituximab in case of B-cell lymphoma
Detailed Description
International, multicentre, randomised, open-label, treatment optimisation study, preceded by safety run-in phases conducted for B-cell and T-cell lymphoma separately.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2025
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT03366272
Start Date
December 5 2017
End Date
January 15 2025
Last Update
January 28 2025
Active Locations (77)
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1
Landeskrankenhaus Feldkirch
Feldkirch, Austria
2
Innsbruck University Hospital
Innsbruck, Austria
3
Kepler Universitätsklinikum GmbH- Med. Campus III
Linz, Austria
4
Ordensklinikum Linz - Elisabethinen
Linz, Austria