A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma (NB001)

St. Petersburg State Pavlov Medical University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hodgkin's Lymphoma

Treatments: Drug: Nivolumab; Drug: Bendamustine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03343652

10/17-n

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

NB

Experimental group

Description:

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

Treatment:

Drug: Bendamustine Hydrochloride

Drug: Nivolumab