Status:
COMPLETED
Safety and Efficacy of Bendamustine, Gemcitabine, Rituximab, Nivolumab (BeGeRN) in Patients With r/r DLBCL
Lead Sponsor:
St. Petersburg State Pavlov Medical University
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Despite the current advances in clinical oncology, the prognosis of patients with resistant diffuse large B cell lymphoma or relapse after high dose chemotherapy is dismal. Therefore there is a need f...
Eligibility Criteria
Inclusion
- Diagnosis: Histologically confirmed diffuse large B-cell lymphoma
- Refractory or relapsed after at least two prior lines of treatment (i.e. induction and salvage regimen) for diffuse large B-cell lymphoma.
- Age 18-70 years old
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
- 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 :
March 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03259529
Start Date
March 27 2017
End Date
January 27 2020
Last Update
June 7 2021
Active Locations (1)
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1
First Pavlov State Medical University of St. Petersburg
Saint Petersburg, Russia, 197089