Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab

Part of paid clinical trials in Encinitas, California.

Sponsor
Amgen
Study ID
NCT02747043
Phase
PHASE3
Status
Completed

Conditions

  • Lymphoma, Non-Hodgkin

Eligibility Criteria

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

Interventions

  • ABP 798 — BIOLOGICAL
    ABP 798 was supplied as a sterile, preservative-free liquid concentrate for IV infusion at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Subjects were to receive premedications before each infusion. Premedications were to be given according to local practice for administration of rituximab therapy.
  • Rituximab — BIOLOGICAL
    Rituximab was procured from commercial supplies in the US and was supplied as a sterile, clear, colorless, preservative-free liquid concentrate for IV infusion at a concentration of 10 mg/mL in either 100-mg/10 mL or 500-mg/50 mL single-dose vials. Subjects were to receive premedications before each infusion. Premedications were to be given according to local practice for administration of rituximab therapy.

Study Details

This was a randomized, double-blind, active-controlled, multiple-dose, clinical similarity study to evaluate the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability and immunogenicity of ABP 798 compared with rituximab in subjects with grade 1, 2, or 3a follicular B-cell NHL and low tumor burden. Subjects were randomized in a 1:1 ratio to receive a 375 mg/m\^2 intravenous infusion of either ABP 798 or rituximab once weekly for 4 weeks followed by dosing at weeks 12 and 20.

Key Dates

Start date
May 25, 2016
Status verified
Sep 2022
Primary completion
Jun 28, 2019
Completion
Jun 28, 2019

Study Design

Enrollment
256 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ABP 798
    ABP 798 was administered at a dose of 375 mg/m\^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
  • Active Comparator: Rituximab
    Rituximab was administered at a dose of 375 mg/m\^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.

Primary Outcome Measure

Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease [ Time Frame: Post treatment up to Week 28 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteEncinitasCalifornia92024-1332-
Research SiteMount SterlingKentucky40353-
Research SiteBillingsMontana59102-
Research SiteZanesvilleOhio43701-
Research SiteRoanokeVirginia24014-

Find similar trials in Encinitas, CA

By research site
Research Site· Encinitas, CAResearch Site· Mount Sterling, KYResearch Site· Billings, MTResearch Site· Zanesville, OHResearch Site· Roanoke, VA

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