A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma

Sponsor
St. Petersburg State Pavlov Medical University
Study ID
NCT03343652
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    3 mg/kg IV infusion on day 1,14 up to 3 cycles
  • Bendamustine Hydrochloride — DRUG
    90 mg/kg IV infusion on day 1 up to 3 cycles

Study Details

A clinical study of safety and efficacy of treatment with Nivolumab and Bendamustine (NB) in patients with relapsed/refractory Hodgkin's lymphoma.

Key Dates

Start date
May 27, 2017
Status verified
May 2020
Primary completion
Mar 27, 2019
Completion
Mar 27, 2020

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NB
    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 Measure

Overall Response Rate (ORR) of Nivolumab in combination with Bendamustine Hydrochloride in patients with Hodgkin's lymphoma [ Time Frame: up to 3 months ]

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