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) - HOVON 153 NHL/ DSHNHL 2015-1 (NIVEAU)

Saarland University, Vice President for Research and Technology0 sites40 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sponsor

Saarland University, Vice President for Research and Technology

•\- 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

•\-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

Not specified