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 Gemcitabine, Oxaliplatin plus Rituximab in case of B-cell lymphoma (NIVEAU)

Phase 3

Recruiting

• Conditions: NHL; Non Hodgkin lymphoma; 10025322

• Registration Number: NL-OMON54592
• Lead Sponsor: Saarland University, Vice President for Research and Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- all patient >65 years of age or older than 18 years if HCT-CI score > 2
- Ineligibility for either autologous or 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 before
entering the study. Rituximab must be part of the first-line regimen in case of
a 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
use any contraceptive method with a failure rate of less than 1% per year
- Written informed consent of the patient

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 nonmelanoma
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 antifungal 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 first line therapy of lymphoma is allowed.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression free survival</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-complete response rate<br /><br>-partial response rate<br /><br>-overall response rate<br /><br>-duration of response<br /><br>-progression rate<br /><br>-rate of treatment-related deaths<br /><br>-relapse rate<br /><br>-Event-free survival<br /><br>-Overall survival<br /><br>-Toxicity<br /><br>-Protocol adherence<br /><br>-quality of life as assessed by the EQ-5D-5L.<br /><br>-outcome according to PD-L1 and PD-1 expression, cell of origin,<br /><br>9p24.1alterations</p><br>