Clincosm LogoSign in Get a demo

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

Sponsor
St. Petersburg State Pavlov Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT03343652
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
34
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
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 :
Mar 27, 2019
Actual Study Completion Date :
Mar 27, 2020

Arms and Interventions

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 Names:
  • Opdivo

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate (ORR) of Nivolumab in combination with Bendamustine Hydrochloride in patients with Hodgkin's lymphoma [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 [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) [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) [up to 12 months]

    4. Progression-Free Survival (PFS) [up to 12 months]

    5. Overall Survival (OS) [up to 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 First Pavlov State Medical University of St. Petersburg Saint-Petersburg Russian Federation 197089

    Sponsors and Collaborators

    • St. Petersburg State Pavlov Medical University

    Investigators

    • Study Director: Boris V Afanasyev, PhD, First Pavlov State Medical University of St. Petersburg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Nov 17, 2017
    Last Update Posted:
    May 28, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ivan S Moiseev, Vice-director for science of R.M. Gorbacheva Memorial Institute of Hematology, Oncology and Transplantation, St. Petersburg State Pavlov Medical University
    Hodgkin's Lymphoma
    Nivolumab
    Bendamustine Hydrochloride
    Additional relevant MeSH terms:
    Lymphoma
    Hodgkin Disease
    Nivolumab
    Bendamustine Hydrochloride

    Study Results

    No Results Posted as of May 28, 2020