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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03343652
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Ivan S Moiseev, St. Petersburg State Pavlov Medical University

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

Condition or disease Intervention/treatment Phase
Hodgkin's Lymphoma Drug: Nivolumab Drug: Bendamustine Hydrochloride Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 27, 2017
Actual Primary Completion Date : March 27, 2019
Actual Study Completion Date : March 27, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NB
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
 Drug: Nivolumab
3 mg/kg IV infusion on day 1,14 up to 3 cycles
Other Name: Opdivo

Drug: Bendamustine Hydrochloride
90 mg/kg IV infusion on day 1 up to 3 cycles
Other Name: Ribomustin


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343652


Locations
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Russian Federation
First Pavlov State Medical University of St. Petersburg
Saint-Petersburg, Russian Federation, 197089
Sponsors and Collaborators
St. Petersburg State Pavlov Medical University
Investigators
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Study Director: Boris V Afanasyev, PhD First Pavlov State Medical University of St. Petersburg
More Information
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Responsible Party: Ivan S Moiseev, Vice-director for science of R.M. Gorbacheva Memorial Institute of Hematology, Oncology and Transplantation, St. Petersburg State Pavlov Medical University
ClinicalTrials.gov Identifier: NCT03343652    
Other Study ID Numbers: 10/17-n
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ivan S Moiseev, St. Petersburg State Pavlov Medical University:
Hodgkin's Lymphoma
Nivolumab
Bendamustine Hydrochloride
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Nivolumab
Bendamustine Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action