Nivolumab Maintenance Therapy After Autologous Stem Cell Transplant in Hodgkin Lymphoma Pts at Relapse/Progression Risk

Part of paid clinical trials in Denver, Colorado.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT03436862
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab 240 mg IV infusion over 60 minutes given every 2 weeks for up to 6 months.

Study Details

This is a Phase II single-arm open-label study of nivolumab as maintenance therapy after autologous stem cell transplantation in patients with Hodgkin lymphoma at risk of relapse or progression.

Key Dates

Start date
May 23, 2018
Status verified
Jun 2023
Primary completion
May 5, 2022
Completion
Apr 4, 2023

Study Design

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

Arms

  • Experimental: Nivolumab
    Patients will receive Nivolumab 240 mg by intravenous infusion (IV) starting Day 45-120 post-transplant (±10 days) every 2 weeks for up to a maximum of 6 months of treatment.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability of Nivolumab as Maintenance Therapy [ Time Frame: Every 2 weeks up to a maximum of 6 months of treatment, then up to 100 days after treatment discontinuation ]

Locations (6)

FacilityCityStateZIPSite coordinators
Colorado Blood Cancer InstituteDenverColorado80218-
HCA MidwestKansas CityMissouri64132-
Tennessee OncologyNashvilleTennessee37203-
St. David's South Austin Medical CenterAustinTexas78704-
Texas Transplant InstituteSan AntonioTexas78229-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Denver, CO

By research site
Colorado Blood Cancer Institute· Denver, COHCA Midwest· Kansas City, MOTennessee Oncology· Nashville, TNSt. David's South Austin Medical Center· Austin, TXTexas Transplant Institute· San Antonio, TXMedical College of Wisconsin· Milwaukee, WI

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