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

St. Petersburg State Pavlov Medical University30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hodgkin's Lymphoma

Interventions

NivolumabDRUG

3 mg/kg IV infusion on day 1,14 up to 3 cycles

Bendamustine HydrochlorideDRUG

90 mg/kg IV infusion on day 1 up to 3 cycles

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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.

Locations (1)

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, Russia

Outcomes

Primary Outcomes

Overall Response Rate (ORR) of Nivolumab in combination with Bendamustine Hydrochloride in patients with Hodgkin's lymphoma

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.

Time frame: up to 3 months

Secondary Outcomes

Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03

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).

Time frame: up to 12 months

Duration of Response (DOR)

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.

Time frame: up to 12 months

Time to Progression (TTP)

Time frame: up to 12 months

Progression-Free Survival (PFS)

Time frame: up to 12 months

Overall Survival (OS)

Time frame: up to 12 months

Data from ClinicalTrials.gov

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