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 - NIVEA

Saarland University0 sites388 target enrollmentJune 3, 2019

Overview

No summary available.

Registry

who.int

Start Date

June 3, 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

•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), in particular:
•? heart: angina pectoris CCS \>2, cardiac failure e.g. NYHA \>2
•? liver: total bilirubin \>1\.5 times the upper reference limit (except
•subjects with Gilbert Syndrome, who can have total bilirubin
•\<51 µmol/l), aspartate transaminase (AST) or alanine
•transaminase (ALT) \>3 x institutional upper reference limit
•? kidney: creatinine clearance \< 30 ml/min