Clinical Trials /

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

NCT02747043

Description:

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with CD 20 positive B-cell non Hodgkin lymphoma. This study will assess if the investigational medicine is safe and effective in treating CD 20 positive B-cell non Hodgkin lymphoma.

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab
  • Official Title: A Randomized, Double-Blind Study Evaluating the Efficacy, Safety and Immunogenicity of ABP 798 Compared With Rituximab in Subjects With CD20 Positive B-Cell Non-Hodgkin Lymphoma (NHL)

Clinical Trial IDs

  • ORG STUDY ID: 20130109
  • NCT ID: NCT02747043

Conditions

  • Lymphoma, Non-Hodgkin

Interventions

DrugSynonymsArms
ABP 798ABP 798
RituximabRituxanRituximab

Purpose

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with CD 20 positive B-cell non Hodgkin lymphoma.

This study will assess if the investigational medicine is safe and effective in treating CD 20 positive B-cell non Hodgkin lymphoma.

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
ABP 798ExperimentalConcentrate for solution for infusion, ABP 798 at a dose of 375 mg/m2 administered as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20
  • ABP 798
    RituximabActive ComparatorConcentrate for solution for infusion, Rituximab at a dose of 375 mg/m2 administered as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20
      • Rituximab

    Eligibility Criteria

    Inclusion Criteria:

    - Males and females ≥ 18 and < 80 years of age

    - Histological confirmed (by lymph node or extranodal region biopsy), Grade 1, 2, or 3a follicular B-cell NHL expressing CD20 within 12 months before randomization

    - Stage 2, 3, or 4 (per Cotswold's Modification of Ann Arbor Staging System) with measurable disease (per International Working Group)

    - subjects must have a baseline scan (computed tomography [CT]) of the neck (if palpable lymph node > 1.0 cm), chest, abdomen, and pelvis to assess disease burden within 28 days before randomization

    - subjects must have had a baseline bone marrow biopsy within 12 months before randomization. Previously confirmed positive bone marrow involvement does not need to be repeated for purposes of screening.

    - Low tumor burden based on the Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria

    - largest nodal or extranodal mass ≤ 7 cm

    - no more than 3 nodal sites with diameter > 3 cm

    - no spleen enlargement by CT assessment

    - no significant pleural or peritoneal serous effusions by CT

    - normal lactate dehydrogenase (LDH)

    - no B symptoms (night sweats, fever [temperature > 38°C], weight loss > 10% in the previous 6 months)

    Exclusion Criteria:

    - Diffuse large cell component and/or Grade 3b follicular NHL

    - History or known presence of central nervous system metastase

    - Palliative radiotherapy within 3 months before randomization

    - Malignancy other than NHL within 5 years (except treated in-situ cervical cancer, or squamous or basal cell carcinoma of the skin)

    - Recent infection requiring a course of systemic anti-infective agents that was completed ≤ 7 days before randomization (with the exception of uncomplicated urinary tract infection)

    - Subject is currently enrolled in or has not yet completed at least 30 days or 5 half-lives (whichever is longer) since ending other investigational device or drug study(s), including vaccines, or subject is receiving other investigational agent(s)

    - Previous use of either commercially available or investigational chemotherapy, biological, or immunological therapy for NHL (including rituximab or biosimilar rituximab, or other anti-CD20 treatments)

    Maximum Eligible Age:80 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Risk difference (RD) of objective response rate (ORR)
    Time Frame:Week 28
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Risk difference of ORR
    Time Frame:Week 12
    Safety Issue:
    Description:
    Measure:Percent of subjects with complete depletion of CD19 cell count and total Immunoglobin G (IgG) and IgM antibody levels
    Time Frame:Baseline to study day 8
    Safety Issue:
    Description:
    Measure:Subject incidence of treatment-emergent AEs and serious adverse events
    Time Frame:Up to Week 28
    Safety Issue:
    Description:Clinical significant changes in laboratory values and vital signs will be reported as AEs
    Measure:Incidence of anti-drug antibodies
    Time Frame:Up to Week 28
    Safety Issue:
    Description:
    Measure:On study progression-free survival
    Time Frame:Up to Week 28
    Safety Issue:
    Description:
    Measure:On study overall survival
    Time Frame:Up to Week 28
    Safety Issue:
    Description:
    Measure:Geometric mean ratio (GMR) of test (ABP 798)-to-reference (rituximab)
    Time Frame:Predose and after end of infusion at week 12
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Amgen

    Trial Keywords

      Last Updated

      November 4, 2016