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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02747043
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE April 19, 2016
First Posted Date  ICMJE April 21, 2016
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE May 25, 2016
Actual Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2017)
  • Risk difference (RD) of objective response rate (ORR) [ Time Frame: Week 28 ]
  • Risk difference (RD) of overall response rate (ORR) [ Time Frame: Week 28 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2016)
Risk difference (RD) of objective response rate (ORR) [ Time Frame: Week 28 ]
Change History Complete list of historical versions of study NCT02747043 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2016)
  • Risk difference of ORR [ Time Frame: Week 12 ]
  • Serum concentrations [ Time Frame: Predose and after end of infusion at 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 ]
  • Clinically significant changes in laboratory values and vital signs [ Time Frame: Up to Week 28 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab
Official Title  ICMJE 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)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, Non-Hodgkin
Intervention  ICMJE
  • Drug: ABP 798
    375 mg/m2, IV (in the vein)
  • Drug: Rituximab
    375 mg/m2, IV (in the vein)
    Other Name: Rituxan
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: Drug: Rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2019)
256
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2016)
250
Actual Study Completion Date  ICMJE June 28, 2019
Actual Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bulgaria,   Canada,   Colombia,   Czechia,   France,   Georgia,   Germany,   Greece,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Poland,   Romania,   Spain,   Ukraine,   United States
Removed Location Countries Czech Republic,   New Zealand
 
Administrative Information
NCT Number  ICMJE NCT02747043
Other Study ID Numbers  ICMJE 20130109
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP