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

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ClinicalTrials.gov Identifier: NCT02747043
Recruitment Status : Recruiting
First Posted : April 21, 2016
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: ABP 798 Drug: Rituximab Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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)
Actual Study Start Date : May 25, 2016
Estimated Primary Completion Date : December 13, 2018
Estimated Study Completion Date : December 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
375 mg/m2, IV (in the vein)
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
375 mg/m2, IV (in the vein)
Other Name: Rituxan


Outcome Measures

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

Secondary Outcome Measures :
  1. Risk difference of ORR [ Time Frame: Week 12 ]
  2. 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 ]
  3. 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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females 18 years of age and older
  • 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 6 weeks 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 splenomegaly > 16cm by CT scan and no symptomatic splenomegaly
    • no significant pleural or peritoneal serous effusions by CT
    • lactate dehydrogenase ≤ upper limit of normal (ULN)
    • 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 metastases
  • 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)
  • Other investigational procedures that can impact the study data, results, or patient safety while participating in this study are excluded; participation in observational studies is allowed.
  • 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)
  • Systemic corticosteroid use within 3 months before randomization (inhaled are allowable)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02747043


Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

  Show 115 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
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
URL: http://

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