A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03888105
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • B-cell Non-Hodgkin Lymphoma (B-NHL)

Eligibility Criteria

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

Interventions

  • Odronextamab — DRUG
    Administered by intravenous (IV) infusion

Study Details

This study is researching an investigational drug, odronextamab, in adult patients B-cell non-Hodgkin's lymphoma (B-NHL). The main purpose of this study is to assess the effectiveness of odronextamab in destroying cancer cells and to learn more about the safety of odronextamab. The study is looking at several other research questions, including: * To see if odronextamab works to destroy cancer cells * Side effects that may be experienced by people taking odronextamab * How odronextamab works in the body * How much odronextamab is present in the blood

Key Dates

Start date
Nov 13, 2019
Status verified
Oct 2025
Primary completion
Jul 6, 2026
Completion
Dec 15, 2028

Study Design

Enrollment
515 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FL
    Follicular lymphoma grade 1-3a cohort
  • Experimental: DLBCL
    Diffuse large B-cell lymphoma cohort
  • Experimental: MCL
    Mantle Cell Lymphoma cohort
  • Experimental: MZL
    Marginal Zone Lymphoma cohort
  • Experimental: Other B-NHL
    Other B-cell non-Hodgkin lymphoma cohort (excluding FL Grade 1-3a, DLBCL, MCL, MZL, Waldenström macroglobulinemia \[WM\]); Patients with a current diagnosis of mixed histology of B-NHL with an aggressive component (such as concurrent FL and DLBCL) will be allowed

Primary Outcome Measure

Objective Response Rate (ORR), as assessed by independent central review [ Time Frame: Up to 52 weeks of study treatment ]

Locations (13)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612-
University of IowaIowa CityIowa52242-
Norton Cancer InstituteLouisvilleKentucky40207-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Tufts Medical CenterBostonMassachusetts02111-
Mayo Clinic - RochesterRochesterMinnesota55905-
John Theurer Cancer Center at Hackensack UMCHackensackNew Jersey07601-
Weill Cornell Medical College New York Presbyterian HospitalNew YorkNew York10021-
Stony Brook University HospitalStony BrookNew York11794-
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27257-
Cleveland Clinic FoundationClevelandOhio44195-
Stephenson Cancer CenterOklahoma CityOklahoma73104-
Harold C. Simmons Comprehensive Cancer CenterDallasTexas75390-

Find similar trials in Chicago, IL

By research site
Rush University Medical Center· Chicago, ILUniversity of Iowa· Iowa City, IANorton Cancer Institute· Louisville, KYBeth Israel Deaconess Medical Center· Boston, MATufts Medical Center· Boston, MAMayo Clinic - Rochester· Rochester, MN

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