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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02747043




Registration number
NCT02747043
Ethics application status
Date submitted
19/04/2016
Date registered
21/04/2016
Date last updated
18/08/2020

Titles & IDs
Public title
Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab
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)
Secondary ID [1] 0 0
2013-005542-11
Secondary ID [2] 0 0
20130109
Universal Trial Number (UTN)
Trial acronym
JASMINE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Non-Hodgkin 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease - 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.
Timepoint [1] 0 0
Post treatment up to Week 28
Secondary outcome [1] 0 0
Percentage of Participants Who Responded (Overall Response Rate - ORR) at Week 12 Based on Independent Central Assessment of Disease - 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.
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Pharmacokinetic Serum Concentrations by Visit - 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.
Timepoint [2] 0 0
Weeks 2, 3, 4, 12 and 20
Secondary outcome [3] 0 0
Percentage of Participants With Complete Depletion of Clusters of Differentiation 19-Positive (CD19+) Cell Count From Baseline to Day 8 - 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.
Timepoint [3] 0 0
Baseline (Day 1), Study Day 8
Secondary outcome [4] 0 0
Total Immunoglobulin G (IgG) Results by Visit - Samples were analyzed by a central lab.
Timepoint [4] 0 0
Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28
Secondary outcome [5] 0 0
Total Immunoglobulin M (IgM) Results by Visit - Samples were analyzed by a central lab.
Timepoint [5] 0 0
Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28
Secondary outcome [6] 0 0
Participants With Treatment-Emergent Adverse Events - 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
Timepoint [6] 0 0
Day 1 (post treatment) to Week 28
Secondary outcome [7] 0 0
Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs) - 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.
Timepoint [7] 0 0
Day 1 (post treatment) to Week 28
Secondary outcome [8] 0 0
Number of Participants Who Developed Anti-drug Antibodies - 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.
Timepoint [8] 0 0
Baseline (Day 1), Weeks 12, 20 and 28
Secondary outcome [9] 0 0
Participants' Progression-Free Survival (PFS) Status Based on the Independent Central Assessment of Disease - PFS was based on disease assessments determined by the central, independent, blinded radiologists' and oncologist's review.
Timepoint [9] 0 0
Day 1 up to Week 28
Secondary outcome [10] 0 0
Percentage of Participants Who Survived -- Overall Survival (OS) - Percentage of participants who were alive at the end of the study.
Timepoint [10] 0 0
Day 1 up to Week 28

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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Gosford
Recruitment hospital [2] 0 0
Research Site - Frankston
Recruitment hospital [3] 0 0
Research Site - Perth
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Montana
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Plovdiv
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Stara Zagora
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Colombia
State/province [9] 0 0
Antioquia
Country [10] 0 0
Colombia
State/province [10] 0 0
Cundinamarca
Country [11] 0 0
Czechia
State/province [11] 0 0
Praha
Country [12] 0 0
Czechia
State/province [12] 0 0
Severomoravsky KRAJ
Country [13] 0 0
France
State/province [13] 0 0
Aquitaine
Country [14] 0 0
France
State/province [14] 0 0
Auvergne
Country [15] 0 0
France
State/province [15] 0 0
Bretagne
Country [16] 0 0
France
State/province [16] 0 0
NORD Pas-de-calais
Country [17] 0 0
France
State/province [17] 0 0
Poitou-charentes
Country [18] 0 0
Georgia
State/province [18] 0 0
Batumi
Country [19] 0 0
Georgia
State/province [19] 0 0
Tbilisi
Country [20] 0 0
Germany
State/province [20] 0 0
Baden-wuerttemberg
Country [21] 0 0
Germany
State/province [21] 0 0
Bayern
Country [22] 0 0
Germany
State/province [22] 0 0
Hessen
Country [23] 0 0
Germany
State/province [23] 0 0
Nordrhein-westfalen
Country [24] 0 0
Germany
State/province [24] 0 0
Sachsen
Country [25] 0 0
Germany
State/province [25] 0 0
Schleswig-holstein
Country [26] 0 0
Greece
State/province [26] 0 0
Attica
Country [27] 0 0
Greece
State/province [27] 0 0
Peloponnese
Country [28] 0 0
India
State/province [28] 0 0
Gujarat
Country [29] 0 0
India
State/province [29] 0 0
Karnataka
Country [30] 0 0
India
State/province [30] 0 0
Maharashtra
Country [31] 0 0
India
State/province [31] 0 0
Rajasthan
Country [32] 0 0
Israel
State/province [32] 0 0
Rehoboth
Country [33] 0 0
Italy
State/province [33] 0 0
Foggia
Country [34] 0 0
Italy
State/province [34] 0 0
Lombardia
Country [35] 0 0
Italy
State/province [35] 0 0
Pesaro E Urbino
Country [36] 0 0
Italy
State/province [36] 0 0
Pordenone
Country [37] 0 0
Italy
State/province [37] 0 0
Torino
Country [38] 0 0
Italy
State/province [38] 0 0
Brescia
Country [39] 0 0
Italy
State/province [39] 0 0
Milano
Country [40] 0 0
Italy
State/province [40] 0 0
Padova
Country [41] 0 0
Italy
State/province [41] 0 0
Parma
Country [42] 0 0
Italy
State/province [42] 0 0
Ravenna
Country [43] 0 0
Italy
State/province [43] 0 0
Rimini
Country [44] 0 0
Italy
State/province [44] 0 0
Terni
Country [45] 0 0
Japan
State/province [45] 0 0
Chiba
Country [46] 0 0
Japan
State/province [46] 0 0
Fukuoka
Country [47] 0 0
Japan
State/province [47] 0 0
Gunma
Country [48] 0 0
Japan
State/province [48] 0 0
Hyogo
Country [49] 0 0
Japan
State/province [49] 0 0
MIE
Country [50] 0 0
Japan
State/province [50] 0 0
Tochigi
Country [51] 0 0
Japan
State/province [51] 0 0
Tokyo
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Gyeonggi-do
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Gyeongsangnam-do
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Daegu
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Seoul
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Ulsan
Country [57] 0 0
Mexico
State/province [57] 0 0
Distrito Federal
Country [58] 0 0
Mexico
State/province [58] 0 0
Chihuahua
Country [59] 0 0
Poland
State/province [59] 0 0
Dolnoslaskie
Country [60] 0 0
Poland
State/province [60] 0 0
Kujawsko-pomorskie
Country [61] 0 0
Poland
State/province [61] 0 0
Malopolskie
Country [62] 0 0
Poland
State/province [62] 0 0
Pomorskie
Country [63] 0 0
Romania
State/province [63] 0 0
Mures
Country [64] 0 0
Romania
State/province [64] 0 0
Timis
Country [65] 0 0
Romania
State/province [65] 0 0
Bucuresti
Country [66] 0 0
Spain
State/province [66] 0 0
Barcelona
Country [67] 0 0
Spain
State/province [67] 0 0
Cordoba
Country [68] 0 0
Spain
State/province [68] 0 0
Madrid
Country [69] 0 0
Spain
State/province [69] 0 0
Santa CRUZ DE Tenerife
Country [70] 0 0
Spain
State/province [70] 0 0
Caceres
Country [71] 0 0
Spain
State/province [71] 0 0
Cadiz
Country [72] 0 0
Spain
State/province [72] 0 0
Salamanca
Country [73] 0 0
Ukraine
State/province [73] 0 0
Kiev
Country [74] 0 0
Ukraine
State/province [74] 0 0
Transcarpathia
Country [75] 0 0
Ukraine
State/province [75] 0 0
Chernivtsi
Country [76] 0 0
Ukraine
State/province [76] 0 0
Dnipropetrovsk

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02747043
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications