Clinical trial · Interventional
Nivolumab With Gemcitabine, Oxaliplatin + Rituximab in r/r Elderly Lymphoma Patients
Improvement of Outcome in Elderly Patients or Patients Not Eligible for High-dose Chemotherapy With Aggressive NHL in First Relapse/Progression by Adding Nivolumab to Gemcitabine, Oxaliplatin Plus Rituximab in Case of B-cell Lymphoma
NCT03366272CI-TRIAL-00085180NIVEAUcompletedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the addition of nivolumab to gemcitabine, oxaliplatin plus rituximab in case of B-cell lymphoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Oxaliplatin | Device | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- (R)-GemOx
- 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)
- interventionNames
- Drug: Rituximab
- Drug: Gemcitabine
- Device: Oxaliplatin
- type
- EXPERIMENTAL
- label
- Nivo-(R)-GemOx
- 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
- interventionNames
- Drug: Nivolumab
- Drug: Rituximab
- Drug: Gemcitabine
- Device: Oxaliplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.