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

• Status: Recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universität des Saarlandes
• Collaborators: Bristol-Myers Squibb; Lymphoma Study Association; University of Leipzig
• Treatments: Gemcitabine; Nivolumab; Oxaliplatin; Rituximab

Criteria

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 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. 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.