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 enrollmentJuly 9, 2019

Overview

No summary available.

Registry

who.int

Start Date

July 9, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Saarland University

•\- all patient \>65 years of age or older than 18 years f not eligible for neither autologous nor allogeneic stem cell transplantation
•\- Ineligibility for neither autologous nor allogeneic stem cell transplantation
•\- All risk groups (IPI 0 to 5\)
•\- 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
•\- Patient must be covered by social security system.
•Are the trial subjects under 18? no

•\- 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), 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
•\- 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.