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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02747043
Registration number
NCT02747043
Ethics application status
Date submitted
19/04/2016
Date registered
21/04/2016
Date last updated
10/09/2022
Titles & IDs
Public title
Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab
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Scientific 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)
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Secondary ID [1]
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2013-005542-11
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Secondary ID [2]
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20130109
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Universal Trial Number (UTN)
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Trial acronym
JASMINE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Non-Hodgkin
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - ABP 798
Other interventions - Rituximab
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.
Other interventions: ABP 798
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.
Other interventions: Rituximab
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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease
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Assessment method [1]
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Overall response within the first treatment cycle was assessed according to International Working Group - Non-Hodgkin Lymphoma criteria (IWG-NHL criteria [Cheson et al, 1999]) by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement), and bone marrow biopsy (to assess bone marrow infiltration). ORR was the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu) or partial response (PR). Participants that do not meet the criteria for response were considered non-responders.
CR was defined as no evidence of disease. CRu showed nodes in the original sum of the products (SPD) regressed by >75% and/or indeterminate bone marrow results.
PR was a = 50% decrease in SPD of the six largest dominant nodes; >=50% decrease in liver and spleen nodes, and no increase in size of other nodes nor any new sites of disease.
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Timepoint [1]
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Post treatment up to Week 28
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Secondary outcome [1]
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Percentage of Participants Who Responded (Overall Response Rate - ORR) at Week 12 Based on Independent Central Assessment of Disease
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Assessment method [1]
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Overall response within the first treatment cycle was assessed according to International Working Group - Non-Hodgkin Lymphoma criteria (IWG-NHL criteria [Cheson et al, 1999]) by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement), and bone marrow biopsy (to assess bone marrow infiltration). ORR was the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu) or partial response (PR). Participants that do not meet the criteria for response were considered non-responders.
CR was defined as no evidence of disease. CRu showed nodes in the original sum of the products (SPD) regressed by >75% and/or indeterminate bone marrow results.
PR was a = 50% decrease in SPD of the six largest dominant nodes; >=50% decrease in liver and spleen nodes, and no increase in size of other nodes nor any new sites of disease.
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Pharmacokinetic Serum Concentrations by Visit
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Assessment method [2]
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Pharmacokinetic serum samples were analyzed by a central lab. Lower limit of quantification (LLOQ) was 0.25 ug/mL. PK concentrations below the lower limit of quantification were assigned a value of 0. Geometric mean and geometric CV were only calculated using concentrations >0.
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Timepoint [2]
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Weeks 2, 3, 4, 12 and 20
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Secondary outcome [3]
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Percentage of Participants With Complete Depletion of Clusters of Differentiation 19-Positive (CD19+) Cell Count From Baseline to Day 8
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Assessment method [3]
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Complete depletion of CD19+ cell count at any postdose time was defined as CD19+ cell counts < 20 cell/µL (0.02 * 10^9 cell/L). Participants with missing CD19+ cell count at baseline or participants with CD19+ cell count < 20 cell/µL at baseline were to be excluded from the derivation of complete depletion of CD19+ cell count.
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Timepoint [3]
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Baseline (Day 1), Study Day 8
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Secondary outcome [4]
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Total Immunoglobulin G (IgG) Results by Visit
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Assessment method [4]
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Samples were analyzed by a central lab.
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Timepoint [4]
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Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28
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Secondary outcome [5]
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Total Immunoglobulin M (IgM) Results by Visit
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Assessment method [5]
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Samples were analyzed by a central lab.
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Timepoint [5]
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Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28
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Secondary outcome [6]
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Participants With Treatment-Emergent Adverse Events
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Assessment method [6]
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An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. Each AE was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard.
IP = investigational product
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Timepoint [6]
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Day 1 (post treatment) to Week 28
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Secondary outcome [7]
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Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
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Assessment method [7]
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The AEOIs prespecified for this study were infusion reactions including hypersensitivity, cardiac disorders, serious infections, progressive multifocal leukoencephalopathy, hematological reactions, hepatitis B reactivation, opportunistic infections, severe mucocutaneous reactions, tumor lysis syndrome, gastrointestinal perforation, and reversible posterior leukoencephalopathy syndrome.
Infusion reactions including hypersensitivity adverse events of interest must have start date the same as, or one day after, an investigational product administration start date.
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Timepoint [7]
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Day 1 (post treatment) to Week 28
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Secondary outcome [8]
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Number of Participants Who Developed Anti-drug Antibodies
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Assessment method [8]
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Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect antibodies capable of binding to ABP 798/rituximab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based assay to determine neutralizing activity against ABP 798/rituximab (Neutralizing Antibody Assay).
Developing antibody incidence was defined as participants with a negative or no binding antibody result at baseline and a positive antibody result at any post-baseline time point.
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Timepoint [8]
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Baseline (Day 1), Weeks 12, 20 and 28
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Secondary outcome [9]
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Participants' Progression-Free Survival (PFS) Status Based on the Independent Central Assessment of Disease
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Assessment method [9]
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PFS was based on disease assessments determined by the central, independent, blinded radiologists' and oncologist's review.
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Timepoint [9]
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Day 1 up to Week 28
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Secondary outcome [10]
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Percentage of Participants Who Survived -- Overall Survival (OS)
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Assessment method [10]
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Percentage of participants who were alive at the end of the study.
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Timepoint [10]
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Day 1 up to Week 28
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/05/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/06/2019
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Sample size
Target
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Accrual to date
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Final
256
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Research Site - Gosford
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Recruitment hospital [2]
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Research Site - Frankston
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Recruitment hospital [3]
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Research Site - Perth
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Recruitment postcode(s) [1]
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2250 - Gosford
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Recruitment postcode(s) [2]
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3199 - Frankston
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Recruitment postcode(s) [3]
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6000 - Perth
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Recruitment outside Australia
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United States of America
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California
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Kentucky
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Ohio
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Bulgaria
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Plovdiv
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Bulgaria
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Stara Zagora
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Ontario
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Colombia
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Antioquia
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Ukraine
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Kiev
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Chernivtsi
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Ukraine
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Dnipropetrovsk
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02747043
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02747043
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