Improvement of Outcome in Elderly Patients or Patients not eligible for high-dose chemotherapy with Aggressive Non-Hodgkin Lymphoma in first Relapse or Progression by adding Nivolumab to a standard chemotherapy.

Phase 1

• Conditions: Patients with first relapse or progression of aggressive Non-Hodgkin’s Lymphoma who are not eligible neither for autologous nor allogeneic stem cell transplantation; MedDRA version: 22.0Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-002272-27-BE
• Lead Sponsor: Saarland University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-27
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 388

Inclusion Criteria

- all patient >65 years of age or older than 18 years if if not eligible for neither autologous nor allogeneic stem cell transplantation
- Ineligibility for neither autologous nor allogeneic stem cell Transplantation
-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
-Performance status ECOG 0 – 2
-Patients must have only one prior chemotherapy regimen including an anthracycline. The last cytotoxic drug must be given at least four weeks prior randomization. Rituximab must be part of the first-line regimen in case of a 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 use any contraceptive method with a failure rate of less than 1% per year
- Written informed consent of the patient

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

Exclusion Criteria

-Already initiated lymphoma therapy after first relapse or progression (except for the prephase Treatment)
-Serious accompanying disorder or impaired organ function (except when due to lymphoma involvement)
-WBC < 2.5 G/l, Neutrophils < 2 G/l, Platelets < 100 G/l (does not apply if cytopenia is caused by lymphoma)
-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
-Patients with an active, known or suspected autoimmune disease
-no requirement for immunosuppressive doses of systemic corticosteroids (except for treatment of lymphoma)
-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 (intracerebral, meningeal, intraspinal intradural) or primary CNS lymphoma
- Persistent neuropathy grade >2 (NCI CTC-AE v4.03) (unless due to lymphoma involvement)
-Pregnancy or breast-feeding women
- Women of childbearing potential (WOCBP)
-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 of allergy 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified