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Completed

NCT Number: NCT03343652

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

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

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Key information

Conditions

Hodgkin's Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, 197089, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nivolumab

Drug

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

Other names: Opdivo

Bendamustine Hydrochloride

Drug

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

Other names: Ribomustin

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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).

  2. Duration of Response (DOR)

    Time frame: 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.

  3. Time to Progression (TTP)

    Time frame: up to 12 months

  4. Progression-Free Survival (PFS)

    Time frame: up to 12 months

  5. Overall Survival (OS)

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

St. Petersburg State Pavlov Medical University

Other

Registry information

Official study title

A Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of Nivolumab and Bendamustine Combination (NB) in Patients With Relapsed or Refractory Hodgkin's Lymphoma

Acronym: NB001

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Nov 17, 2017
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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