Back to resultsStudy to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab (JASMINE)
Primary Purpose
Lymphoma, Non-Hodgkin
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ABP 798
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring CD20 Positive B-cell Non-Hodgkin Lymphoma, ABP 798
Eligibility Criteria
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)
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ABP 798
Rituximab
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Total Immunoglobulin G (IgG) Results by Visit
Samples were analyzed by a central lab.
Total Immunoglobulin M (IgM) Results by Visit
Samples were analyzed by a central lab.
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
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.
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.
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.
Percentage of Participants Who Survived -- Overall Survival (OS)
Percentage of participants who were alive at the end of the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02747043
Brief Title
Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab
Acronym
JASMINE
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 25, 2016 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
June 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
Keywords
CD20 Positive B-cell Non-Hodgkin Lymphoma, ABP 798
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABP 798
Arm Type
Experimental
Arm Description
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.
Arm Title
Rituximab
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
ABP 798
Other Intervention Name(s)
biosimilar to rituximab
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease
Description
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.
Time Frame
Post treatment up to Week 28
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Responded (Overall Response Rate - ORR) at Week 12 Based on Independent Central Assessment of Disease
Description
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.
Time Frame
Week 12
Title
Pharmacokinetic Serum Concentrations by Visit
Description
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.
Time Frame
Weeks 2, 3, 4, 12 and 20
Title
Percentage of Participants With Complete Depletion of Clusters of Differentiation 19-Positive (CD19+) Cell Count From Baseline to Day 8
Description
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.
Time Frame
Baseline (Day 1), Study Day 8
Title
Total Immunoglobulin G (IgG) Results by Visit
Description
Samples were analyzed by a central lab.
Time Frame
Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28
Title
Total Immunoglobulin M (IgM) Results by Visit
Description
Samples were analyzed by a central lab.
Time Frame
Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28
Title
Participants With Treatment-Emergent Adverse Events
Description
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
Time Frame
Day 1 (post treatment) to Week 28
Title
Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
Description
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.
Time Frame
Day 1 (post treatment) to Week 28
Title
Number of Participants Who Developed Anti-drug Antibodies
Description
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.
Time Frame
Baseline (Day 1), Weeks 12, 20 and 28
Title
Participants' Progression-Free Survival (PFS) Status Based on the Independent Central Assessment of Disease
Description
PFS was based on disease assessments determined by the central, independent, blinded radiologists' and oncologist's review.
Time Frame
Day 1 up to Week 28
Title
Percentage of Participants Who Survived -- Overall Survival (OS)
Description
Percentage of participants who were alive at the end of the study.
Time Frame
Day 1 up to Week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024-1332
Country
United States
Facility Name
Research Site
City
Mount Sterling
State/Province
Kentucky
ZIP/Postal Code
40353
Country
United States
Facility Name
Research Site
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Research Site
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Research Site
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Research Site
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Research Site
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Research Site
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Research Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Research Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
Country
Canada
Facility Name
Research Site
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050034
Country
Colombia
Facility Name
Research Site
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
110111
Country
Colombia
Facility Name
Research Site
City
Praha 5
State/Province
Praha
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Research Site
City
Ostrava - Poruba
State/Province
Severomoravsky KRAJ
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Research Site
City
Bordeaux Cedex
State/Province
Aquitaine
ZIP/Postal Code
33077
Country
France
Facility Name
Research Site
City
Clermont Ferrand
State/Province
Auvergne
ZIP/Postal Code
63050
Country
France
Facility Name
Research Site
City
Cesson-Sevigne
State/Province
Bretagne
ZIP/Postal Code
35576
Country
France
Facility Name
Research Site
City
Boulogne sur Mer
State/Province
NORD Pas-de-calais
ZIP/Postal Code
62321
Country
France
Facility Name
Research Site
City
La Rochelle
State/Province
Poitou-charentes
ZIP/Postal Code
17000
Country
France
Facility Name
Research Site
City
Poitiers Cedex
State/Province
Poitou-charentes
ZIP/Postal Code
86021
Country
France
Facility Name
Research Site
City
Batumi
ZIP/Postal Code
6000
Country
Georgia
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Research Site
City
Freiburg
State/Province
Baden-wuerttemberg
ZIP/Postal Code
79110
Country
Germany
Facility Name
Research Site
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86156
Country
Germany
Facility Name
Research Site
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
Research Site
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34125
Country
Germany
Facility Name
Research Site
City
Münster
State/Province
Nordrhein-westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Research Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Research Site
City
Flensburg
State/Province
Schleswig-holstein
ZIP/Postal Code
24939
Country
Germany
Facility Name
Research Site
City
Athens
State/Province
Attica
ZIP/Postal Code
11525
Country
Greece
Facility Name
Research Site
City
Athens
State/Province
Attica
ZIP/Postal Code
11527
Country
Greece
Facility Name
Research Site
City
Patra
State/Province
Peloponnese
ZIP/Postal Code
26504
Country
Greece
Facility Name
Research Site
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395010
Country
India
Facility Name
Research Site
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390001
Country
India
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560068
Country
India
Facility Name
Research Site
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575001
Country
India
Facility Name
Research Site
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422004
Country
India
Facility Name
Research Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 001
Country
India
Facility Name
Research Site
City
Bikaner
State/Province
Rajasthan
ZIP/Postal Code
334 003
Country
India
Facility Name
Research Site
City
Be'er Ya'akov
State/Province
Rehoboth
ZIP/Postal Code
7030000
Country
Israel
Facility Name
Research Site
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Research Site
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Facility Name
Research Site
City
Pesaro
State/Province
Pesaro E Urbino
ZIP/Postal Code
61100
Country
Italy
Facility Name
Research Site
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Facility Name
Research Site
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Facility Name
Research Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20153
Country
Italy
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Research Site
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Research Site
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Research Site
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Facility Name
Research Site
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Research Site
City
Chiba-city
State/Province
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Research Site
City
Maebashi-city
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Research Site
City
Kobe-city
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Research Site
City
Tsu
State/Province
MIE
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Research Site
City
Utsunomiya City
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
Research Site
City
Tachikawa-city
State/Province
Tokyo
ZIP/Postal Code
190-0014
Country
Japan
Facility Name
Research Site
City
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
Research Site
City
Seoul
State/Province
Gyeonggi-do
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
State/Province
Gyeonggi-do
ZIP/Postal Code
158-710
Country
Korea, Republic of
Facility Name
Research Site
City
Busan
State/Province
Gyeongsangnam-do
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Research Site
City
Jinju-si
State/Province
Gyeongsangnam-do
ZIP/Postal Code
52727
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
41931
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Research Site
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
01120
Country
Mexico
Facility Name
Research Site
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Facility Name
Research Site
City
Legnica
State/Province
Dolnoslaskie
ZIP/Postal Code
59-220
Country
Poland
Facility Name
Research Site
City
Toruń
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Research Site
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Research Site
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-219
Country
Poland
Facility Name
Research Site
City
Targu-Mures
State/Province
Mures
ZIP/Postal Code
540042
Country
Romania
Facility Name
Research Site
City
Targu-Mures
State/Province
Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Research Site
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300021
Country
Romania
Facility Name
Research Site
City
Bucuresti
ZIP/Postal Code
030171
Country
Romania
Facility Name
Research Site
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Research Site
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Research Site
City
La Laguna Tenerife
State/Province
Santa CRUZ DE Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Research Site
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Research Site
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Site
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Research Site
City
Kyiv
State/Province
Kiev
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Research Site
City
Kyiv
State/Province
Kiev
ZIP/Postal Code
04112
Country
Ukraine
Facility Name
Research Site
City
Uzhgorod
State/Province
Transcarpathia
ZIP/Postal Code
88014
Country
Ukraine
Facility Name
Research Site
City
Chernivtsi
ZIP/Postal Code
58013
Country
Ukraine
Facility Name
Research Site
City
Dnipropetrovsk
ZIP/Postal Code
49055
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://www.amgen.com/datasharing
Citations:
PubMed Identifier
33044684
Citation
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.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab
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