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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02747043
First received: April 19, 2016
Last updated: November 4, 2016
Last verified: November 2016
  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.


Condition Intervention Phase
Lymphoma, Non-Hodgkin
Drug: ABP 798
Drug: Rituximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Risk difference (RD) of objective response rate (ORR) [ Time Frame: Week 28 ]

Secondary Outcome Measures:
  • Risk difference of ORR [ Time Frame: Week 12 ]
  • 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 ]
  • Subject incidence of treatment-emergent AEs and serious adverse events [ Time Frame: Up to Week 28 ]
    Clinical significant changes in laboratory values and vital signs will be reported as AEs

  • Incidence of anti-drug antibodies [ Time Frame: Up to Week 28 ]
  • On study progression-free survival [ Time Frame: Up to Week 28 ]
  • On study overall survival [ Time Frame: Up to Week 28 ]
  • Geometric mean ratio (GMR) of test (ABP 798)-to-reference (rituximab) [ Time Frame: Predose and after end of infusion at week 12 ]

Estimated Enrollment: 250
Study Start Date: May 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABP 798
Concentrate 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
Drug: ABP 798
Active Comparator: Rituximab
Concentrate 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
Drug: Rituximab
Other Name: Rituxan

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02747043

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 45 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02747043     History of Changes
Other Study ID Numbers: 20130109
Study First Received: April 19, 2016
Last Updated: November 4, 2016

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 28, 2017