Status:
COMPLETED
A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma
Lead Sponsor:
St. Petersburg State Pavlov Medical University
Conditions:
Hodgkin's Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
A clinical study of safety and efficacy of treatment with Nivolumab and Bendamustine (NB) in patients with relapsed/refractory Hodgkin's lymphoma.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03343652
Start Date
May 27 2017
End Date
March 27 2020
Last Update
May 28 2020
Active Locations (1)
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1
First Pavlov State Medical University of St. Petersburg
Saint Petersburg, Russia, 197089