Overview

A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma

Status:
Completed
Trial end date:
2020-03-27
Target enrollment:
0
Participant gender:
All
Summary
A clinical study of safety and efficacy of treatment with Nivolumab and Bendamustine (NB) in patients with relapsed/refractory Hodgkin's lymphoma.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
St. Petersburg State Pavlov Medical University
Treatments:
Antibodies, Monoclonal
Bendamustine Hydrochloride
Nivolumab
Criteria
Inclusion Criteria:

- Diagnosis: Histologically confirmed Hodgkin's lymphoma

- Relapsed or refractory to at least two prior treatment lines

- Relapsed after nivolumab treatment or refractory to nivolumab treatment

- Age 18-70 years old

- Signed informed consent

- No severe concurrent illness

Exclusion Criteria:

- Uncontrolled bacterial or fungal infection at the time of enrollment

- Requirement for vasopressor support at the time of enrollment

- Karnofsky index <30%

- Pregnancy

- Somatic or psychiatric disorder making the patient unable to sign informed consent

- Active or prior documented autoimmune disease requiring systemic treatment.