Overview
A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma
Status:
Completed
Completed
Trial end date:
2020-03-27
2020-03-27
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
St. Petersburg State Pavlov Medical UniversityTreatments:
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.