A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma
NB001
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
1 other identifier
interventional
30
1 country
1
Brief Summary
A clinical study of safety and efficacy of treatment with Nivolumab and Bendamustine (NB) in patients with relapsed/refractory Hodgkin's lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2017
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 27, 2017
CompletedFirst Submitted
Initial submission to the registry
November 12, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2020
CompletedMay 28, 2020
May 1, 2020
1.8 years
November 12, 2017
May 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
up to 3 months
Secondary Outcomes (5)
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
up to 12 months
Duration of Response (DOR)
up to 12 months
Time to Progression (TTP)
up to 12 months
Progression-Free Survival (PFS)
up to 12 months
Overall Survival (OS)
up to 12 months
Study Arms (1)
NB
EXPERIMENTALNivolumab 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
Interventions
90 mg/kg IV infusion on day 1 up to 3 cycles
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Pavlov State Medical University of St. Petersburg
Saint Petersburg, 197089, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Boris V Afanasyev, PhD
First Pavlov State Medical University of St. Petersburg
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice-director for science of R.M. Gorbacheva Memorial Institute of Hematology, Oncology and Transplantation
Study Record Dates
First Submitted
November 12, 2017
First Posted
November 17, 2017
Study Start
May 27, 2017
Primary Completion
March 27, 2019
Study Completion
March 27, 2020
Last Updated
May 28, 2020
Record last verified: 2020-05