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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Treatment: Other - ABP 798
Treatment: Other - 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.


Treatment: Other: 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.

Treatment: Other: 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
Treatment: Other
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
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
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Pharmacokinetic Serum Concentrations by Visit
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
Timepoint [3] 0 0
Baseline (Day 1), Study Day 8
Secondary outcome [4] 0 0
Total Immunoglobulin G (IgG) Results by Visit
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
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
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)
Timepoint [7] 0 0
Day 1 (post treatment) to Week 28
Secondary outcome [8] 0 0
Number of Participants Who Developed Anti-drug Antibodies
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
Timepoint [9] 0 0
Day 1 up to Week 28
Secondary outcome [10] 0 0
Percentage of Participants Who Survived -- Overall Survival (OS)
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
Sex
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
25/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/06/2019
Sample size
Target
Accrual to date
Final
256
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/study/NCT02747043
Trial related presentations / publications
Niederwieser D, Hamm C, Cobb P, Mo M, Forsyth C, Tucci A, Hanes V, Delwail V, Hajek R, Chien D. Efficacy and Safety of ABP 798: Results from the JASMINE Trial in Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product. Target Oncol. 2020 Oct;15(5):599-611. doi: 10.1007/s11523-020-00748-4. Erratum In: Target Oncol. 2020 Dec;15(6):807. doi: 10.1007/s11523-020-00772-4.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02747043