search
Back to results

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

Primary Purpose

Hodgkin's Lymphoma

Status
Completed
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Nivolumab
Bendamustine Hydrochloride
Sponsored by
St. Petersburg State Pavlov Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin's Lymphoma focused on measuring Hodgkin's Lymphoma, Nivolumab, Bendamustine Hydrochloride

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • First Pavlov State Medical University of St. Petersburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NB

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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 to Progression (TTP)
Progression-Free Survival (PFS)
Overall Survival (OS)

Full Information

First Posted
November 12, 2017
Last Updated
May 27, 2020
Sponsor
St. Petersburg State Pavlov Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT03343652
Brief Title
A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma
Acronym
NB001
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 27, 2017 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
March 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Petersburg State Pavlov Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Lymphoma
Keywords
Hodgkin's Lymphoma, Nivolumab, Bendamustine Hydrochloride

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NB
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
3 mg/kg IV infusion on day 1,14 up to 3 cycles
Intervention Type
Drug
Intervention Name(s)
Bendamustine Hydrochloride
Other Intervention Name(s)
Ribomustin
Intervention Description
90 mg/kg IV infusion on day 1 up to 3 cycles
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) of Nivolumab in combination with Bendamustine Hydrochloride in patients with Hodgkin's lymphoma
Description
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 Outcome Measure Information:
Title
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
Description
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
Title
Duration of Response (DOR)
Description
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
Title
Time to Progression (TTP)
Time Frame
up to 12 months
Title
Progression-Free Survival (PFS)
Time Frame
up to 12 months
Title
Overall Survival (OS)
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris V Afanasyev, PhD
Organizational Affiliation
First Pavlov State Medical University of St. Petersburg
Official's Role
Study Director
Facility Information:
Facility Name
First Pavlov State Medical University of St. Petersburg
City
Saint-Petersburg
ZIP/Postal Code
197089
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs