Gemcitabine, Bendamustine, and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT03739619
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Classical Hodgkin Lymphoma
  • Hodgkin Lymphoma
  • Recurrent Hodgkin Lymphoma
  • Refractory Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bendamustine — DRUG
    Given IV
  • Gemcitabine — DRUG
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

This phase I/II trial studies the side effects and best dose of gemcitabine, bendamustine, and nivolumab when given together and to see how well they work in treating patients with classic Hodgkin lymphoma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as gemcitabine and bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving gemcitabine, bendamustine, and nivolumab may work better in treating patients with classic Hodgkin lymphoma.

Key Dates

Start date
Nov 26, 2018
Status verified
Jul 2025
Primary completion
Dec 22, 2023
Completion
Apr 30, 2025

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine, bendamustine, nivolumab
    Patients receive gemcitabine IV over 30 minutes on day 1, bendamustine IV over 30 minutes on days 1 and 2, and nivolumab over 60 minutes IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive nivolumab IV over 60 minutes on day 1. Treatment with single agent nivolumab repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerable Dose (Phase I) [ Time Frame: Up to completion of course 2 at 42 days after study start ]

Locations (2)

FacilityCityStateZIP
Emory Saint Joseph's HospitalAtlantaGeorgia30342
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322

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Emory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GA

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