A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma
- Conditions
- Hodgkin's Lymphoma
- Interventions
- Registration Number
- NCT03343652
- Lead Sponsor
- St. Petersburg State Pavlov Medical University
- Brief Summary
A clinical study of safety and efficacy of treatment with Nivolumab and Bendamustine (NB) in patients with relapsed/refractory Hodgkin's lymphoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NB Bendamustine Hydrochloride Nivolumab 3 mg/kg IV infusion on day 1,14 + Bendamustine hydrochloride 90 mg/kg IV infusion on day 1,2 up to 3 cycles. Duration of cycle 28 days NB Nivolumab Nivolumab 3 mg/kg IV infusion on day 1,14 + Bendamustine hydrochloride 90 mg/kg IV infusion on day 1,2 up to 3 cycles. Duration of cycle 28 days
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) of Nivolumab in combination with Bendamustine Hydrochloride in patients with Hodgkin's lymphoma up to 3 months Overall response rate (ORR), defined as proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC criteria and duration of response.
- Secondary Outcome Measures
Name Time Method Time to Progression (TTP) up to 12 months Progression-Free Survival (PFS) up to 12 months Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03 up to 12 months Toxicity parameters based on NCI CTCAE 4.03 grades: hematological toxicity (CBC), hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), fatigue (attending physician assessment), rash (attending physician assessment), colitis (attending physician assessment), pneumonitis (attending physician assessment), autoimmune disorders (level of hormones, presence of autoimmune antibodies, attending physician assessment).
Overall Survival (OS) up to 12 months Duration of Response (DOR) up to 12 months Duration of response will be measured from the time of initial response to nivolumab till documented disease progression, death or last evaluation of tumor status.
Trial Locations
- Locations (1)
First Pavlov State Medical University of St. Petersburg
🇷🇺Saint-Petersburg, Russian Federation