Trial Outcomes & Findings for MabionCD20 Compared to MabThera in Lymphoma Patients (NCT NCT02617485)
NCT ID: NCT02617485
Last Updated: 2023-10-25
Results Overview
Area under the serum concentration-time curve from time zero (Day 1) to final time point measured after the first administration (Week 1) until Week 4 (AUC(W1-W4)). PK blood samples for this endpoint were drawn at Day 1 (before and after the first infusion), Day 8 ± 1 (7 days after first infusion), Day 15 ± 1 (14 days after first infusion), Day 22 ± 2 (before and after completion of the second infusion).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
143 participants
Primary outcome timeframe
Baseline to Week 4
Results posted on
2023-10-25
Participant Flow
The trial was initiated in 7 countries (Croatia, Bosnia and Herzegovina, Georgia, Moldova, Poland, Serbia, and Ukraine), but finally only 5 countries with 21 study sites recruited patients (Bosnia and Herzegovina, Georgia, Moldova, Poland, and Ukraine). Start date of recruitment: 29.03.2016
Screening lasted 28 days (from Day -35 to -8 before randomization), during which the eligibility status of patients was verified. Forty-eight patients were excluded before randomization: 45 patients did not meet eligibility criteria, one patient declined participation and two patients could not be randomized because of the limited availability of investigational drugs.
Participant milestones
| Measure |
MabionCD20
Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
Patients randomly assigned to MabionCD20 were followed up until Week 46.
|
MabThera
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
Patients randomly assigned to MabThera were followed up until Week 46.
|
|---|---|---|
|
Treatment and Observation Period
STARTED
|
100
|
40
|
|
Treatment and Observation Period
COMPLETED
|
85
|
35
|
|
Treatment and Observation Period
NOT COMPLETED
|
15
|
5
|
|
Follow-up Period
STARTED
|
85
|
35
|
|
Follow-up Period
COMPLETED
|
70
|
29
|
|
Follow-up Period
NOT COMPLETED
|
15
|
6
|
Reasons for withdrawal
| Measure |
MabionCD20
Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
Patients randomly assigned to MabionCD20 were followed up until Week 46.
|
MabThera
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
Patients randomly assigned to MabThera were followed up until Week 46.
|
|---|---|---|
|
Treatment and Observation Period
Adverse Event
|
9
|
1
|
|
Treatment and Observation Period
Withdrawal by Subject
|
4
|
1
|
|
Treatment and Observation Period
Patient needed radiotherapy
|
1
|
0
|
|
Treatment and Observation Period
Lack of Efficacy
|
1
|
2
|
|
Treatment and Observation Period
Physician Decision
|
0
|
1
|
|
Follow-up Period
Adverse Event
|
1
|
0
|
|
Follow-up Period
Withdrawal by Subject
|
1
|
0
|
|
Follow-up Period
Disease progression
|
2
|
1
|
|
Follow-up Period
Need for CNS prophylaxis
|
1
|
0
|
|
Follow-up Period
Patient needed radiotherapy
|
9
|
5
|
|
Follow-up Period
Patient needed bone marrow transplantation
|
1
|
0
|
Baseline Characteristics
MabionCD20 Compared to MabThera in Lymphoma Patients
Baseline characteristics by cohort
| Measure |
MabionCD20
n=100 Participants
Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
MabThera
n=40 Participants
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
78 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
54.3 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
52.3 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
100 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BSA
|
1.9 cubic metre
STANDARD_DEVIATION 0.2 • n=5 Participants
|
1.8 cubic metre
STANDARD_DEVIATION 0.2 • n=7 Participants
|
1.8 cubic metre
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Body weight
|
76.2 kilograms
STANDARD_DEVIATION 17.4 • n=5 Participants
|
73.6 kilograms
STANDARD_DEVIATION 17 • n=7 Participants
|
75.5 kilograms
STANDARD_DEVIATION 17.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: PP W1-4 set (subset of ITT population based on patients without major protocol deviations to Week 4 (visit 4) and having a PK assessment on this visit. Completion of the study was not necessary for inclusion into this population).
Area under the serum concentration-time curve from time zero (Day 1) to final time point measured after the first administration (Week 1) until Week 4 (AUC(W1-W4)). PK blood samples for this endpoint were drawn at Day 1 (before and after the first infusion), Day 8 ± 1 (7 days after first infusion), Day 15 ± 1 (14 days after first infusion), Day 22 ± 2 (before and after completion of the second infusion).
Outcome measures
| Measure |
MabionCD20
n=94 Participants
Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
MabThera
n=35 Participants
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
|---|---|---|
|
Area Under the Serum Concentration-time Curve From Day 1 to Week 4 (AUC[1-4])
|
1559.51 (μg*day)/mL
Standard Deviation 358.092
|
1509.79 (μg*day)/mL
Standard Deviation 382.559
|
PRIMARY outcome
Timeframe: Week 13 to Week 26Population: PP W13-26 set (subset of ITT population based on patients without major protocol deviations and having a PK assessment from Week 13 to Week 26).
Area under the serum concentration-time curve from time zero to final time point measured from Week 13 until Week 26 (AUC\[W13-W26\]). PK blood samples for this endpoint were drawn at Day 85 ± 4 (before and after completion of the fifth infusion), Day 106 ± 4 (before and after completion of sixth infusion), Day 127 ± 4 (before and after completion of the seventh infusion), Day 148 ± 4 (before and after completion of the eight infusion), Day 155 ± 4 (one week after last infusion) and Day 176 ± 4 (one month after last infusion).
Outcome measures
| Measure |
MabionCD20
n=74 Participants
Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
MabThera
n=29 Participants
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
|---|---|---|
|
Area Under the Serum Concentration-time Curve From Week 13 to Week 26 (AUC[W13-W26])
|
16498.9 (μg*day)/mL
Standard Deviation 3492.39
|
15647.4 (μg*day)/mL
Standard Deviation 3629.83
|
SECONDARY outcome
Timeframe: Week 22Population: PP W13-26 set (subset of ITT population based on patients without major protocol deviations and having a PK assessment from Week 13 to Week 26).
Trough serum concentration measured at the end of a dosing interval at steady state, taken directly before eighth infusion.
Outcome measures
| Measure |
MabionCD20
n=74 Participants
Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
MabThera
n=29 Participants
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
|---|---|---|
|
Ctrough (Before 8th Infusion)
|
102.246 μg/mL
Standard Deviation 43.897
|
90.61 μg/mL
Standard Deviation 41.994
|
SECONDARY outcome
Timeframe: Week 13 (5th infusion) and Week 22 (8th infusion)Population: PP W13-26 set (subset of ITT population based on patients without major protocol deviations and having a PK assessment from Week 13 to Week 26).
Maximum serum drug concentration (Cmax) at steady state after the 5th and 8th infusions.
Outcome measures
| Measure |
MabionCD20
n=74 Participants
Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
MabThera
n=29 Participants
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
|---|---|---|
|
Cmax (Post 5th and 8th Infusion)
5th infusion
|
273.356 μg/mL
Standard Deviation 65.452
|
266.439 μg/mL
Standard Deviation 66.086
|
|
Cmax (Post 5th and 8th Infusion)
8th infusion
|
296.784 μg/mL
Standard Deviation 58.295
|
296.462 μg/mL
Standard Deviation 69.641
|
SECONDARY outcome
Timeframe: Week 13 (5th infusion) and Week 22 (8th infusion)Population: PP W13-26 set (subset of ITT population based on patients without major protocol deviations and having a PK assessment from Week 13 to Week 26).
Elimination Rate Constant at steady stade after the 5th and 8th infusions.
Outcome measures
| Measure |
MabionCD20
n=74 Participants
Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
MabThera
n=29 Participants
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
|---|---|---|
|
Kel (Post 5th and 8th Infusions)
5th infusion
|
0.05663 1/day
Standard Deviation 0.01794
|
0.05418 1/day
Standard Deviation 0.01884
|
|
Kel (Post 5th and 8th Infusions)
8th infusion
|
0.04335 1/day
Standard Deviation 0.01528
|
0.04379 1/day
Standard Deviation 0.0123
|
SECONDARY outcome
Timeframe: Week 13 to Week 16 and Week 22 to Week 26Population: PP W13-26 set (subset of ITT population based on patients without major protocol deviations and having a PK assessment from Week 13 to Week 26).
Elimination half-life at steady state after the 5th and 8th infusions.
Outcome measures
| Measure |
MabionCD20
n=74 Participants
Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
MabThera
n=29 Participants
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
|---|---|---|
|
T1/2 (Post 5th and 8th Infusions)
5th infusion
|
14.801 days
Standard Deviation 12.218
|
15.217 days
Standard Deviation 7.889
|
|
T1/2 (Post 5th and 8th Infusions)
8th infusion
|
18.301 days
Standard Deviation 7.92
|
16.997 days
Standard Deviation 4.515
|
SECONDARY outcome
Timeframe: Week 13 to Week 16 and Week 22 to Week 26Population: PP W13-26 set (subset of ITT population based on patients without major protocol deviations and having a PK assessment from Week 13 to Week 26).
Clearance at steady state after the 5th and 8th infusions.
Outcome measures
| Measure |
MabionCD20
n=74 Participants
Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
MabThera
n=29 Participants
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
|---|---|---|
|
CLss (Post 5th and 8th Infusions)
5th infusion
|
198.701 mL/day
Standard Deviation 53.427
|
206.905 mL/day
Standard Deviation 78.213
|
|
CLss (Post 5th and 8th Infusions)
8th infusion
|
179.168 mL/day
Standard Deviation 58.509
|
191.272 mL/day
Standard Deviation 89.016
|
SECONDARY outcome
Timeframe: baseline to Week 26Population: ITT set (a subset of safety population based on patients who had at least one complete post baseline assessment of the area under the serum concentration-time curve from time zero to final time point (AUC(0-t)), measured after the first administration (Week 1) until the second administration at Week 4(AUC(1-4)).
Area under the serum concentration-time curve of CD19+ B cell counts, measured from the first administration to the final time point at Week 26 (AUC(1-26) B-cell).
Outcome measures
| Measure |
MabionCD20
n=98 Participants
Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
MabThera
n=38 Participants
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
|---|---|---|
|
AUC (W1-W26) B-cell
|
3395.82 cells*days/mL blood
Standard Deviation 22364.5
|
10476.2 cells*days/mL blood
Standard Deviation 56943.0
|
SECONDARY outcome
Timeframe: Week 1 until Week 26Population: PP W1-W26 set
Area under the serum concentration-time curve measured after the first administration (Week 1) until Week 26 (AUC(1-26))
Outcome measures
| Measure |
MabionCD20
n=71 Participants
Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
MabThera
n=28 Participants
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
|---|---|---|
|
AUC (W1-W26)
|
28413.6 (μg*day)/mL
Standard Deviation 5194.98
|
26955.3 (μg*day)/mL
Standard Deviation 5849.22
|
SECONDARY outcome
Timeframe: Week 26Population: ITT population including all randomized patients
An efficacy assessment was made after 8 treatment cycles (at Week 26) based on tumour responses classified according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (Cheson et al. 1999). Response was assessed based on clinical, radiologic (CT scan) and pathologic (bone marrow) criteria. Possible efficacy responses were: complete response, partial response, stable disease, and progressive disease. Efficacy reported here includes all patients included in the ITT set.
Outcome measures
| Measure |
MabionCD20
n=100 Participants
Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
MabThera
n=40 Participants
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
|---|---|---|
|
Efficacy Assessment at Week 26
Complete
|
34 Participants
|
14 Participants
|
|
Efficacy Assessment at Week 26
Partial
|
42 Participants
|
18 Participants
|
|
Efficacy Assessment at Week 26
Stable disease
|
10 Participants
|
4 Participants
|
|
Efficacy Assessment at Week 26
Progressive disease
|
10 Participants
|
2 Participants
|
|
Efficacy Assessment at Week 26
Missing
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: from baseline to Week 46Population: SAF set (all patients randomized into the study and receiving at least one infusion of MabionCD20 or MabThera).
Percentage of patients with at least one AE in a given category. Data from the entire follow-up are included (Period 1 and Period 2).
Outcome measures
| Measure |
MabionCD20
n=100 Participants
Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
MabThera
n=40 Participants
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
|---|---|---|
|
Adverse Events
severe TEAEs
|
40.0 percent
|
22.5 percent
|
|
Adverse Events
related TEAEs
|
53.0 percent
|
42.5 percent
|
|
Adverse Events
related severe TEAEs
|
29.0 percent
|
22.5 percent
|
|
Adverse Events
related TESAEs
|
13.0 percent
|
5.0 percent
|
|
Adverse Events
all AEs
|
71.0 percent
|
67.5 percent
|
|
Adverse Events
TEAEs
|
71.0 percent
|
65.0 percent
|
|
Adverse Events
TESAEs
|
19.0 percent
|
12.5 percent
|
|
Adverse Events
TEAEs leading to death
|
8.0 percent
|
0 percent
|
|
Adverse Events
related TEAEs leading to death
|
2.0 percent
|
0 percent
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from baseline to Week 46Population: SAF set (sample from one patient not collected)
Percentage of patients with positive ADA or NAb results in a given category. Data pertain to the entire follow-up period (from Baseline to Week 46).
Outcome measures
| Measure |
MabionCD20
n=99 Participants
Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
MabThera
n=40 Participants
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
|---|---|---|
|
Immunogenicity
Treatment-induced ADA
|
6 participants
|
1 participants
|
|
Immunogenicity
Persistent ADA
|
4 participants
|
1 participants
|
|
Immunogenicity
Transient ADA
|
2 participants
|
0 participants
|
|
Immunogenicity
Treatment-boosted ADA
|
0 participants
|
0 participants
|
|
Immunogenicity
NAb positive
|
0 participants
|
0 participants
|
Adverse Events
MabionCD20
Serious events: 19 serious events
Other events: 70 other events
Deaths: 8 deaths
MabThera
Serious events: 5 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MabionCD20
n=100 participants at risk
Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
MabThera
n=40 participants at risk
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Cardiac disorders
Atrial flutter
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Cardiac disorders
Cardiac failure
|
2.0%
2/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
General disorders
Death
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
General disorders
Disease progression
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Infections and infestations
Bronchitis
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Infections and infestations
Lung infection
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Infections and infestations
Pneumonia
|
3.0%
3/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Infections and infestations
Sepsis
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
3.0%
3/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
2/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Vascular disorders
Hypotension
|
2.0%
2/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
Other adverse events
| Measure |
MabionCD20
n=100 participants at risk
Patients assigned to this arm received 375 mg/m2 of MabionCD20 intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
MabThera
n=40 participants at risk
Patients assigned to this arm received 375 mg/m2 of MabThera intravenously every 3 weeks for 8 cycles on Days 1, 22 (Week 4), 43 (Week 7), 64 (Week 10), 85 (Week 13), 106 (Week 16), 127 (Week 19), and 148 (Week 22).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.0%
14/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
12.5%
5/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.0%
3/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Blood and lymphatic system disorders
Leukopenia
|
22.0%
22/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
25.0%
10/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Blood and lymphatic system disorders
Neutropenia
|
29.0%
29/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
25.0%
10/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Cardiac disorders
Cardiomyopathy
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Cardiac disorders
Sinus tachycardia
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.0%
2/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
3/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
7.5%
3/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
2.0%
2/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Gastrointestinal disorders
Stomatitis
|
3.0%
3/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
5.0%
2/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
2/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
General disorders
Asthenia
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
General disorders
Chest pain
|
2.0%
2/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
General disorders
Chills
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
General disorders
Face oedema
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
General disorders
Fatigue
|
5.0%
5/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
General disorders
Hyperthermia
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
General disorders
Pyrexia
|
5.0%
5/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Infections and infestations
Bronchitis
|
2.0%
2/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Infections and infestations
Infection
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Infections and infestations
Influenza
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Infections and infestations
Lung infection
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Infections and infestations
Pneumonia
|
5.0%
5/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Infections and infestations
Respiratory tract infection
|
7.0%
7/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Infections and infestations
Respiratory tract infection viral
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Infections and infestations
Viral infection
|
2.0%
2/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.0%
3/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
4/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Investigations
Aspartate aminitransferase increased
|
3.0%
3/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.0%
1/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Investigations
Monocyte count increased
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Investigations
Neutrophil count decreased
|
8.0%
8/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
10.0%
4/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Investigations
Platelet count decreased
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Investigations
Transaminases increased
|
3.0%
3/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
5.0%
2/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Investigations
White blood count decreased
|
9.0%
9/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
10.0%
4/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
2.0%
2/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Nervous system disorders
Headache
|
4.0%
4/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Psychiatric disorders
Insomnia
|
2.0%
2/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
2/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
0.00%
0/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.0%
15/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
12.5%
5/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
|
Vascular disorders
Hypertension
|
2.0%
2/100 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
2.5%
1/40 • 46 weeks
AEs were collected at each trial visit and followed up 30 days after patients completed the trial.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place