Lymphoma, Non-HodgkinPhase 3JASMINENCT02747043
Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab
A Phase 3 study testing ABP 798 and Rituximab in people with Lymphoma, Non-Hodgkin, run by Amgen at 98 sites in 20 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- ABP 798 and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 98 sitesin 20 countries
- Study dates
- 25 May 2016to 28 Jun 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
98 sites in 20 countries.
98 sites in 20 countries
Italy13 sites
Research Site
Aviano, Pordenone, 33081
Research Site
Bergamo, Lombardy, 24127
Research Site
Brescia, 25123
Research Site
Candiolo, Torino, 10060
Research Site
Milan, 20141
Research Site
Milan, 20153
Research Site
Padova, 35128
Research Site
Parma, 43126
Research Site
Pesaro, Pesaro E Urbino, 61100
Research Site
Ravenna, 48100
Research Site
Rimini, 47900
Research Site
San Giovanni Rotondo, Foggia, 71013
Research Site
Terni, 05100
South Korea10 sites
Research Site
Daegu, 41931
Research Site
Daegu, 42415
Research Site
Jinju, Gyeongsangnam-do, 52727
Research Site
Pusan, Gyeongsangnam-do, 48108
Research Site
Seoul, Gyeonggi-do, 135-710
Research Site
Seoul, Gyeonggi-do, 158-710
Research Site
Seoul, 03080
Research Site
Seoul, 03181
Research Site
Seoul, 03722
Research Site
Ulsan, 44033
Spain9 sites
Research Site
Barcelona, 08003
Research Site
Cáceres, 10003
Research Site
Cadiz, 11009
Research Site
Córdoba, Cordoba, 14004
Research Site
La Laguna Tenerife, Santa CRUZ DE Tenerife, 38320
Research Site
Madrid, 28046
Research Site
Majadahonda, Madrid, 28222
Research Site
Sabadell, Barcelona, 08208
Research Site
Salamanca, 37007
Japan8 sites
Research Site
Chiba, Chiba, 260-8717
Research Site
Fukuoka, Fukuoka, 811-1395
Research Site
Kobe, Hyōgo, 650-0047
Research Site
Maebashi, Gunma, 371-8511
Research Site
Tachikawa, Tokyo, 190-0014
Research Site
Tokyo, 150-8935
Research Site
Tsu, Mie-ken, 514-8507
Research Site
Utsunomiya, Tochigi, 320-0834
Germany7 sites
Research Site
Augsburg, Bavaria, 86156
Research Site
Flensburg, Schleswig-Holstein, 24939
Research Site
Freiburg im Breisgau, Baden-Wurttemberg, 79110
Research Site
Kassel, Hesse, 34125
Research Site
Leipzig, Saxony, 04103
Research Site
Münster, North Rhine-Westphalia, 48149
Research Site
Würzburg, Bavaria, 97080
India7 sites
Research Site
Bangalore, Karnataka, 560068
Research Site
Bikaner, Rajasthan, 334 003
Research Site
Mangalore, Karnataka, 575001
Research Site
Nashik, Maharashtra, 422004
Research Site
Pune, Maharashtra, 411 001
Research Site
Surat, Gujarat, 395010
Research Site
Vadodara, Gujarat, 390001
France6 sites
Research Site
Bordeaux, Aquitaine, 33077
Research Site
Boulogne-sur-Mer, Hauts-de-France, 62321
Research Site
Cesson-Sévigné, Brittany Region, 35576
Research Site
Clermont-Ferrand, Auvergne, 63050
Research Site
La Rochelle, Poitou-charentes, 17000
Research Site
Poitiers, Poitou-charentes, 86021
United States5 sites
Research Site
Billings, Montana, 59102
Research Site
Encinitas, California, 92024-1332
Research Site
Mount Sterling, Kentucky, 40353
Research Site
Roanoke, Virginia, 24014
Research Site
Zanesville, Ohio, 43701
Ukraine5 sites
Research Site
Chernivtsi, 58013
Research Site
Dnipropetrovsk, 49055
Research Site
Kyiv, Kyiv City, 03115
Research Site
Kyiv, Kyiv City, 04112
Research Site
Uzhhorod, Zakarpattia Oblast, 88014
Georgia4 sites
Research Site
Batumi, 6000
Research Site
Tbilisi, 0112
Research Site
Tbilisi, 0160
Research Site
Tbilisi, 0186
Poland4 sites
Research Site
Gdansk, Pomeranian Voivodeship, 80-219
Research Site
Krakow, Lesser Poland Voivodeship, 31-826
Research Site
Legnica, Lower Silesian Voivodeship, 59-220
Research Site
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
Romania4 sites
Research Site
Bucharest, 030171
Research Site
Târgu Mureş, Mureș County, 540042
Research Site
Târgu Mureş, Mureș County, 540136
Research Site
Timișoara, Timiș County, 300021
Australia3 sites
Research Site
Frankston, Victoria, 3199
Research Site
Gosford, New South Wales, 2250
Research Site
Perth, Western Australia, 6000
Greece3 sites
Research Site
Athens, Attica, 11525
Research Site
Athens, Attica, 11527
Research Site
Patra, Peloponnese, 26504
Colombia2 sites
Research Site
Bogota, Cundinamarca, 110111
Research Site
Medellín, Antioquia, 050034
Czechia2 sites
Research Site
Ostrava - Poruba, Severomoravsky KRAJ, 708 52
Research Site
Prague, Prague, 150 06
Mexico2 sites
Research Site
Chihuahua City, 31203
Research Site
Mexico City, Mexico City, 01120
About this study
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)
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.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- ABP 798, Rituximab
- Keywords
- CD20 Positive B-cell Non-Hodgkin Lymphoma, ABP 798
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABP 798Biological
Also called biosimilar to rituximab
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.
RituximabBiological
Also called Rituxan
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.
| Study group | Role | What they receive |
|---|---|---|
| ABP 798 | Experimental | 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. Receives: Biological: ABP 798 |
| Rituximab | Active comparator | 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. Receives: Biological: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post treatment up to Week 28
Secondary outcomes (10)
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.
Measured: Week 12
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.
Measured: Weeks 2, 3, 4, 12 and 20
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.
Measured: Baseline (Day 1), Study Day 8
Total Immunoglobulin G (IgG) Results by Visit
Samples were analyzed by a central lab.
Measured: Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28
Total Immunoglobulin M (IgM) Results by Visit
Samples were analyzed by a central lab.
Measured: Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28
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
Measured: Day 1 (post treatment) to Week 28
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.
Measured: Day 1 (post treatment) to Week 28
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.
Measured: Baseline (Day 1), Weeks 12, 20 and 28
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.
Measured: Day 1 up to Week 28
Percentage of Participants Who Survived -- Overall Survival (OS)
Percentage of participants who were alive at the end of the study.
Measured: Day 1 up to Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start25 May 2016
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747043
- Sponsor's protocol ID
- 20130109
- Other IDs
- 2013-005542-11
- Acronym
- JASMINE
- Status last verified
- Sep 2022
- First submitted
- 19 Apr 2016
- Last updated
- 10 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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.
PubMed 33044684
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02747043
- Acronym / sponsor ID
- JASMINE / 20130109
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- CD20 Positive B-cell Non-Hodgkin Lymphoma, ABP 798
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 25 May 2016 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Posted 18 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABP 798 | Experimental | Biological: ABP 798ABP 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. |
| Rituximab | Active comparator | Biological: RituximabRituximab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
- Low tumor burden based on the Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABP 798Also: biosimilar to rituximabABP 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. | Biological | ABP 798 |
| RituximabAlso: RituxanRituximab 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. | Biological | Rituximab |
Primary outcome
Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease
Time frame: Post treatment up to Week 28
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.
10 secondary outcomes
Percentage of Participants Who Responded (Overall Response Rate - ORR) at Week 12 Based on Independent Central Assessment of Disease
Time frame: Week 12
Pharmacokinetic Serum Concentrations by Visit
Time frame: Weeks 2, 3, 4, 12 and 20
Percentage of Participants With Complete Depletion of Clusters of Differentiation 19-Positive (CD19+) Cell Count From Baseline to Day 8
Time frame: Baseline (Day 1), Study Day 8
Total Immunoglobulin G (IgG) Results by Visit
Time frame: Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28
Total Immunoglobulin M (IgM) Results by Visit
Time frame: Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28
Participants With Treatment-Emergent Adverse Events
Time frame: Day 1 (post treatment) to Week 28
Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
Time frame: Day 1 (post treatment) to Week 28
Number of Participants Who Developed Anti-drug Antibodies
Time frame: Baseline (Day 1), Weeks 12, 20 and 28
Participants' Progression-Free Survival (PFS) Status Based on the Independent Central Assessment of Disease
Time frame: Day 1 up to Week 28
Percentage of Participants Who Survived -- Overall Survival (OS)
Time frame: Day 1 up to Week 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33044684Niederwieser 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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
98 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ABP 798 and Rituximab in people with Lymphoma, Non-Hodgkin, run by Amgen at 98 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 98 sites in Italy, South Korea, Spain, Japan, Germany and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease (time frame: Post treatment up to Week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02747043, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.