Status:
COMPLETED
Treatment With Nivolumab at the Fixed Dose 40 mg (Nivo40) in Patients With Relapsed/Refractory Hodgkins Lymphoma
Lead Sponsor:
St. Petersburg State Pavlov Medical University
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
A phase I/II trial to evaluate the safety and efficacy of nivolumab at the fixed dose 40 mg in patients with relapsed or refractory Hodgkins lymphoma.
Eligibility Criteria
Inclusion
- Diagnosis: Histologically confirmed Hodgkins lymphoma
- Relapsed or refractory disease after at least two prior lines of 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 :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03343665
Start Date
August 1 2017
End Date
December 20 2019
Last Update
January 23 2020
Active Locations (1)
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1
First Pavlov State Medical University of St. Petersburg
Saint Petersburg, Russia, 197089