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Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab (JASMINE)

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ClinicalTrials.gov Identifier: NCT02747043
Recruitment Status : Completed
First Posted : April 21, 2016
Results First Posted : August 18, 2020
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lymphoma, Non-Hodgkin
Interventions Biological: ABP 798
Biological: Rituximab
Enrollment 256
Recruitment Details A total of 380 subjects were screened and 256 participants (128 in the ABP 798 treatment group and 128 in the rituximab treatment group) were randomized at 91 centers across 20 countries.
Pre-assignment Details Participants were randomized centrally to receive either ABP 798 or rituximab in a 1:1 manner. The randomization was stratified based on geographic region (Europe, Americas, Japan, Asia Pacific - Other) and age group (> 60 years of age, ≤ 60 years of age).
Arm/Group Title ABP 798 Rituximab
Hide Arm/Group 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.
Period Title: Overall Study
Started 128 128
Treated 128 126
Completed [1] 118 123
Not Completed 10 5
Reason Not Completed
Other             1             1
Adverse Event             3             1
Withdrawal by Subject             1             1
Physician Decision             1             1
Protocol Violation             0             1
Disease progression             4             0
[1]
Completed Week 28
Arm/Group Title ABP 798 Rituximab Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 128 128 256
Hide Baseline Analysis Population Description
Enrolled
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants 128 participants 256 participants
57.6  (12.72) 58.2  (12.20) 57.9  (12.45)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 128 participants 256 participants
<= 60 years
71
  55.5%
70
  54.7%
141
  55.1%
> 60 years
57
  44.5%
58
  45.3%
115
  44.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 128 participants 256 participants
Female
68
  53.1%
62
  48.4%
130
  50.8%
Male
60
  46.9%
66
  51.6%
126
  49.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 128 participants 256 participants
White
102
  79.7%
101
  78.9%
203
  79.3%
Asian, Non-Japanese
17
  13.3%
14
  10.9%
31
  12.1%
Asian, Japanese
7
   5.5%
8
   6.3%
15
   5.9%
Missing
1
   0.8%
2
   1.6%
3
   1.2%
Other
0
   0.0%
2
   1.6%
2
   0.8%
American Indian or Alaska Native
1
   0.8%
0
   0.0%
1
   0.4%
White, Asian-Non-Japanese
0
   0.0%
1
   0.8%
1
   0.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 128 participants 256 participants
Not Hispanic or Latino
119
  93.0%
119
  93.0%
238
  93.0%
Hispanic or Latino
8
   6.3%
7
   5.5%
15
   5.9%
Not allowed to collect
1
   0.8%
2
   1.6%
3
   1.2%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 128 participants 128 participants 256 participants
75.29  (19.135) 75.19  (16.981) 75.24  (18.063)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 128 participants 128 participants 256 participants
166.81  (10.737) 167.64  (10.292) 167.22  (10.506)
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 128 participants 256 participants
Grade 0
107
  83.6%
110
  85.9%
217
  84.8%
Grade 1
21
  16.4%
18
  14.1%
39
  15.2%
[1]
Measure Description: Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 128 participants 256 participants
Europe
88
  68.8%
86
  67.2%
174
  68.0%
Asia Pacific - Other
23
  18.0%
23
  18.0%
46
  18.0%
Americas
10
   7.8%
11
   8.6%
21
   8.2%
Japan
7
   5.5%
8
   6.3%
15
   5.9%
Time Since Original Diagnosis  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 128 participants 128 participants 256 participants
6.31  (16.325) 5.17  (10.181) 5.74  (13.590)
Previous Radiation Treatment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 128 participants 256 participants
Yes
3
   2.3%
3
   2.3%
6
   2.3%
No
125
  97.7%
125
  97.7%
250
  97.7%
1.Primary Outcome
Title Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The modified full analysis set included all randomized participants with evidence of disease at baseline per the tumor assessment from the central, independent, blinded assessments. Analyses for the modified full analysis set was based on randomized treatment assignment.
Arm/Group Title ABP 798 Rituximab
Hide Arm/Group 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.
Overall Number of Participants Analyzed 123 124
Measure Type: Number
Unit of Measure: percentage of participants
78.0 70.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Clinical equivalence of the primary endpoint will first be demonstrated by comparing the 1-sided 95% lower confidence limit of the RD of ORR by week 28 between ABP 798 and rituximab with a noninferiority margin of -15%. If this is successful, the 1-sided upper 95% confidence limit of the RD of ORR by week 28 will be compared with a nonsuperiority margin of +35.5%.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 7.7
Confidence Interval (2-Sided) 90%
-1.4 to 16.8
Estimation Comments The 2-sided 90% confidence limits of the risk difference (RD) of ORR by week 28 used a generalized linear model adjusted for the stratification factors (geographic region and age group).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 7.7
Confidence Interval (2-Sided) 95%
-3.2 to 18.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Responded (Overall Response Rate - ORR) at Week 12 Based on Independent Central Assessment of Disease
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The modified full analysis set included all randomized participants with evidence of disease at baseline per the tumor assessment from the central, independent, blinded assessments. Analyses for the modified full analysis set was based on randomized treatment assignment.
Arm/Group Title ABP 798 Rituximab
Hide Arm/Group 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.
Overall Number of Participants Analyzed 123 124
Measure Type: Number
Unit of Measure: percentage of participants
59.3 58.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab
Comments The 2-sided 90% confidence limits of the risk difference (RD) of ORR at week 12 used a generalized linear model adjusted for the stratification factors (geographic region and age group).
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.9
Confidence Interval (2-Sided) 90%
-9.3 to 11.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab
Comments The 2-sided 95% confidence limits of the risk difference (RD) of ORR at week 12 used a generalized linear model adjusted for the stratification factors (geographic region and age group).
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-11.3 to 13.2
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Pharmacokinetic Serum Concentrations by Visit
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set of participants with available data. Participants with PK concentrations below the lower limit of quantification (LLOQ) were excluded from these analyses.
Arm/Group Title ABP 798 Rituximab
Hide Arm/Group 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.
Overall Number of Participants Analyzed 128 126
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram/mL
Week 2 (predose) Number Analyzed 123 participants 125 participants
58.66
(50.4%)
58.63
(76.9%)
Week 3 (predose) Number Analyzed 125 participants 126 participants
105.39
(37.8%)
108.77
(59.1%)
Week 4 (predose) Number Analyzed 126 participants 121 participants
132.70
(42.6%)
140.23
(57.9%)
Week 12 (predose) Number Analyzed 121 participants 124 participants
21.86
(156.1%)
20.55
(194.1%)
Week 12 (postdose) Number Analyzed 113 participants 117 participants
207.05
(58.1%)
209.14
(66.8%)
Week 20 (predose) Number Analyzed 118 participants 122 participants
13.37
(138.7%)
16.45
(115.8%)
4.Secondary Outcome
Title Percentage of Participants With Complete Depletion of Clusters of Differentiation 19-Positive (CD19+) Cell Count From Baseline to Day 8
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants with available data. 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.
Arm/Group Title ABP 798 Rituximab
Hide Arm/Group 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.
Overall Number of Participants Analyzed 115 116
Measure Type: Number
Unit of Measure: percentage of participants
98.3 98.3
5.Secondary Outcome
Title Total Immunoglobulin G (IgG) Results by Visit
Hide Description Samples were analyzed by a central lab.
Time Frame Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants with available data
Arm/Group Title ABP 798 Rituximab
Hide Arm/Group 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.
Overall Number of Participants Analyzed 128 128
Mean (Standard Deviation)
Unit of Measure: g/L
Baseline Number Analyzed 127 participants 123 participants
9.740  (2.5988) 10.570  (2.5970)
Day 8 (Week 2) Number Analyzed 122 participants 123 participants
9.790  (2.5719) 10.486  (2.4916)
Week 3 Number Analyzed 122 participants 123 participants
9.545  (2.5933) 10.374  (2.3214)
Week 4 Number Analyzed 124 participants 121 participants
9.744  (2.5805) 10.196  (2.2842)
Week 28 Number Analyzed 103 participants 104 participants
9.846  (2.6316) 10.281  (2.3617)
6.Secondary Outcome
Title Total Immunoglobulin M (IgM) Results by Visit
Hide Description Samples were analyzed by a central lab.
Time Frame Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants with available data.
Arm/Group Title ABP 798 Rituximab
Hide Arm/Group 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.
Overall Number of Participants Analyzed 128 128
Mean (Standard Deviation)
Unit of Measure: g/L
Baseline Number Analyzed 127 participants 123 participants
1.021  (1.0072) 1.247  (3.4018)
Day 8 (Week 2) Number Analyzed 122 participants 123 participants
1.004  (1.0300) 1.280  (3.7292)
Week 3 Number Analyzed 122 participants 122 participants
1.001  (1.0564) 1.370  (5.0250)
Week 4 Number Analyzed 124 participants 120 participants
0.985  (1.0459) 1.385  (5.3266)
Week 28 Number Analyzed 103 participants 104 participants
0.816  (0.8505) 1.127  (3.6752)
7.Secondary Outcome
Title Participants With Treatment-Emergent Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title ABP 798 Rituximab
Hide Arm/Group 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.
Overall Number of Participants Analyzed 128 126
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
107
  83.6%
95
  75.4%
Any grade >=3 AE
14
  10.9%
13
  10.3%
Any fatal AE
0
   0.0%
0
   0.0%
Any serious AE
5
   3.9%
5
   4.0%
Any AE leading to discontinuation of IP
4
   3.1%
1
   0.8%
Any AE leading to dose delay/withheld IP
9
   7.0%
9
   7.1%
8.Secondary Outcome
Title Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title ABP 798 Rituximab
Hide Arm/Group 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.
Overall Number of Participants Analyzed 128 126
Measure Type: Number
Unit of Measure: percentage of participants
Any AEOI 49.2 45.2
Infusion reactions including hypersensitivity 43.0 42.9
Hematological reactions 5.5 4.8
Cardiac disorders 2.3 1.6
Serious infections 1.6 0
Severe mucocutaneous reactions 0.8 0
Gastrointestinal perforation 0 0
Hepatitis B reactivation 0 0
Opportunistic infection 0 0
Progressive multifocal leukoencephalopathy 0 0
Reversible posterior leukoencephalopathy 0 0
Tumor lysis syndrome 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab
Comments Percentage risk difference for 'Any adverse event of interest'
Type of Statistical Test Other
Comments Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n < 25 for either treatment.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 4.0
Confidence Interval (2-Sided) 95%
-8.3 to 16.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab
Comments Percentage risk difference for 'Infusion reactions including hypersensitivity'
Type of Statistical Test Other
Comments Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n < 25 for either treatment.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-12.1 to 12.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab
Comments Percentage risk difference for 'Hematological reactions'
Type of Statistical Test Other
Comments Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n < 25 for either treatment.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-11.8 to 13.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab
Comments Percentage risk difference in 'Cardiac disorders'
Type of Statistical Test Other
Comments Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n < 25 for either treatment.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-11.8 to 13.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab
Comments Percentage risk difference in 'Serious infections'
Type of Statistical Test Other
Comments Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n < 25 for either treatment.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
-10.9 to 14.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab
Comments Percentage risk difference in 'Severe mucocutaneous reactions'
Type of Statistical Test Other
Comments Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n < 25 for either treatment.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-11.7 to 13.2
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants Who Developed Anti-drug Antibodies
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title ABP 798 Rituximab
Hide Arm/Group 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.
Overall Number of Participants Analyzed 126 123
Measure Type: Count of Participants
Unit of Measure: Participants
Binding antibody positive
3
   2.4%
1
   0.8%
Neutralizing antibody positive
1
   0.8%
1
   0.8%
10.Secondary Outcome
Title Participants' Progression-Free Survival (PFS) Status Based on the Independent Central Assessment of Disease
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title ABP 798 Rituximab
Hide Arm/Group 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.
Overall Number of Participants Analyzed 128 126
Measure Type: Number
Unit of Measure: percentage of participants
Participants with disease progression or death 3.1 2.4
Participants alive and progression-free 96.9 97.6
11.Secondary Outcome
Title Percentage of Participants Who Survived -- Overall Survival (OS)
Hide Description Percentage of participants who were alive at the end of the study.
Time Frame Day 1 up to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title ABP 798 Rituximab
Hide Arm/Group 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.
Overall Number of Participants Analyzed 128 126
Measure Type: Number
Unit of Measure: percentage of participants
100 100
Time Frame Day 1 to 28 weeks
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title ABP 798 Rituximab
Hide Arm/Group 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.
All-Cause Mortality
ABP 798 Rituximab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/128 (0.00%)   0/126 (0.00%) 
Hide Serious Adverse Events
ABP 798 Rituximab
Affected / at Risk (%) Affected / at Risk (%)
Total   5/128 (3.91%)   5/126 (3.97%) 
Cardiac disorders     
Coronary artery stenosis  1  0/128 (0.00%)  1/126 (0.79%) 
Gastrointestinal disorders     
Abdominal pain  1  0/128 (0.00%)  1/126 (0.79%) 
Colitis ulcerative  1  0/128 (0.00%)  1/126 (0.79%) 
Dysphagia  1  0/128 (0.00%)  1/126 (0.79%) 
Stomatitis  1  1/128 (0.78%)  0/126 (0.00%) 
General disorders     
Chills  1  0/128 (0.00%)  1/126 (0.79%) 
Pyrexia  1  1/128 (0.78%)  0/126 (0.00%) 
Infections and infestations     
Lower respiratory tract infection  1  1/128 (0.78%)  0/126 (0.00%) 
Septic shock  1  1/128 (0.78%)  0/126 (0.00%) 
Viral infection  1  1/128 (0.78%)  0/126 (0.00%) 
Injury, poisoning and procedural complications     
Hip fracture  1  1/128 (0.78%)  0/126 (0.00%) 
Limb traumatic amputation  1  1/128 (0.78%)  0/126 (0.00%) 
Nervous system disorders     
Headache  1  0/128 (0.00%)  1/126 (0.79%) 
Reproductive system and breast disorders     
Erectile dysfunction  1  0/128 (0.00%)  1/126 (0.79%) 
Respiratory, thoracic and mediastinal disorders     
Rhinorrhoea  1  0/128 (0.00%)  1/126 (0.79%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ABP 798 Rituximab
Affected / at Risk (%) Affected / at Risk (%)
Total   59/128 (46.09%)   61/126 (48.41%) 
Gastrointestinal disorders     
Abdominal pain  1  4/128 (3.13%)  9/126 (7.14%) 
Diarrhoea  1  3/128 (2.34%)  9/126 (7.14%) 
Nausea  1  6/128 (4.69%)  14/126 (11.11%) 
General disorders     
Asthenia  1  12/128 (9.38%)  6/126 (4.76%) 
Fatigue  1  13/128 (10.16%)  12/126 (9.52%) 
Pyrexia  1  8/128 (6.25%)  8/126 (6.35%) 
Infections and infestations     
Upper respiratory tract infection  1  7/128 (5.47%)  1/126 (0.79%) 
Nervous system disorders     
Headache  1  15/128 (11.72%)  12/126 (9.52%) 
Respiratory, thoracic and mediastinal disorders     
Throat irritation  1  9/128 (7.03%)  8/126 (6.35%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  6/128 (4.69%)  12/126 (9.52%) 
Rash  1  9/128 (7.03%)  6/126 (4.76%) 
Urticaria  1  7/128 (5.47%)  2/126 (1.59%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
EMail: medinfo@amgen.com
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02747043    
Other Study ID Numbers: 20130109
2013-005542-11 ( EudraCT Number )
First Submitted: April 19, 2016
First Posted: April 21, 2016
Results First Submitted: June 26, 2020
Results First Posted: August 18, 2020
Last Update Posted: August 18, 2020