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

S

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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