Improvement of Outcome in Elderly Patients or Patients not eligible forhigh-dose chemotherapy with Aggressive Non-Hodgkin Lymphoma infirst Relapse or Progression by adding Nivolumab to Gemcitabine,Oxaliplatin plus Rituximab in case of B-cell lymphoma. - NIVEA

Saarland University0 sites388 target enrollmentMay 14, 2019

Overview

No summary available.

Registry

who.int

Start Date

May 14, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Saarland University

•1\. Age: all patient \>65 years of age or \> 18 years if not eligible for neither
•autologous nor allogeneic stem cell transplantation
•2\. Ineligibility for neither autologous nor allogeneic stem cell transplantation as defined as:
•\>65 years of age or
•older than 18 years if HCT\-CI score \> 2 (cf. Appendix 24\.2\) or patients who underwent prior autologous stem cell transplantation and are not eligible for allogeneic stem cell transplantation
•3\. Risk group: All risk groups (IPI 0 to 5\)
•4\. Histology: 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.
•5\. Performance status: Performance status ECOG 0 – 2\.
•6\. Previous therapy: 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 B\-cell lymphoma. Patients may have received prior radiation therapy as part of their first\-line therapy.
•7\. 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.

•1\. Already initiated lymphoma therapy after first relapse or progression (except for the prephase treatment, cf. 8\.6\.1\).
•2\. Serious accompanying disorder or impaired organ function (except when due to lymphoma involvement)
•3\. WBC \< 2\.5 G/l, Neutrophils \< 2 G/l, Platelets \< 100 G/l (does not apply if cytopenia is caused by lymphoma)
•4\. 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.
•5\. Family history for Long QT\-syndrome
•6\. Patients with an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
•7\. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (\> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration (except for treatment of lymphoma).
•8\. Chronic active hepatitis B or C as defined either HBs Ag positive or HBc Ac positive with detectable viral DNA or hepatitis C virus ribonucleic acid positive.
•9\. HIV\-infection
•10\. Patients with a severe immunodeficiency