Trial Outcomes & Findings for Study of SyB L-0501 in Combination With Rituximab to Treat Relapsed/Refractory Diffuse Large B-Cell Lymphoma (NCT NCT01118845)
NCT ID: NCT01118845
Last Updated: 2013-07-04
Results Overview
CR: Disappearance of all evidence of disease. PR: Regression of measurable disease and no new sites. For the criteria for CR, See Outcome measure 2 description. The criteria for PR is as below. Nodal Masses: more than 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes 1. FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site 2. Variably FDG-avid or PET negative; regression on CT Spleen, Liver: more than 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
up to 30 weeks
Results posted on
2013-07-04
Participant Flow
Among the 63 subjects enrolled in the study, 59 subjects received study drug and four subjects were excluded before the first study drug administration. The reasons for exclusion were adverse events and major protocol deviation/violation for two subjects each.
Participant milestones
| Measure |
SyB L-0501
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
42
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of SyB L-0501 in Combination With Rituximab to Treat Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
SyB L-0501
n=59 Participants
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
Age Continuous
|
64.2 Year
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Age, Customized
20-29 years
|
0.0 Percentage of participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
1.7 Percentage of participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
8.5 Percentage of participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
16.9 Percentage of participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
39.0 Percentage of participants
n=5 Participants
|
|
Age, Customized
70-75 years
|
33.9 Percentage of participants
n=5 Participants
|
|
Age, Customized
<65 years
|
37.3 Percentage of participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
62.7 Percentage of participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
42.4 percentage of participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
57.6 percentage of participants
n=5 Participants
|
|
Diagnosis of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
|
100.0 percentage of participants
n=5 Participants
|
|
Clinical Stage (Ann Arbor staging)
Stage I
|
5.1 Percentage of participants
n=5 Participants
|
|
Clinical Stage (Ann Arbor staging)
Stage I-E
|
3.4 Percentage of participants
n=5 Participants
|
|
Clinical Stage (Ann Arbor staging)
Stage II
|
27.1 Percentage of participants
n=5 Participants
|
|
Clinical Stage (Ann Arbor staging)
Stage II-E
|
3.4 Percentage of participants
n=5 Participants
|
|
Clinical Stage (Ann Arbor staging)
Stage III
|
25.4 Percentage of participants
n=5 Participants
|
|
Clinical Stage (Ann Arbor staging)
Stage III-S
|
6.8 Percentage of participants
n=5 Participants
|
|
Clinical Stage (Ann Arbor staging)
Stage III-E
|
3.4 Percentage of participants
n=5 Participants
|
|
Clinical Stage (Ann Arbor staging)
Stage III-SE
|
0.0 Percentage of participants
n=5 Participants
|
|
Clinical Stage (Ann Arbor staging)
Stage IV
|
25.4 Percentage of participants
n=5 Participants
|
|
Clinical Stage (Ann Arbor staging)
Unknown
|
0.0 Percentage of participants
n=5 Participants
|
|
Systemic symptoms (B symptoms) (Ann Arbor staging)
Asymptomatic
|
86.4 Percentage of participants
n=5 Participants
|
|
Systemic symptoms (B symptoms) (Ann Arbor staging)
Symptomatic
|
13.6 Percentage of participants
n=5 Participants
|
|
Systemic symptoms (B symptoms) (Ann Arbor staging)
Unknown
|
0.0 Percentage of participants
n=5 Participants
|
|
Medical history of diffuse large B-cell lymphoma (DLBCL)
No
|
40.7 Percentage of participants
n=5 Participants
|
|
Medical history of diffuse large B-cell lymphoma (DLBCL)
Yes
|
59.3 Percentage of participants
n=5 Participants
|
|
Complications of DLBCL
No
|
6.8 Percentage of participants
n=5 Participants
|
|
Complications of DLBCL
Yes
|
93.2 Percentage of participants
n=5 Participants
|
|
Prior medication/therapy for DLBCL
No
|
8.5 Percentage of participants
n=5 Participants
|
|
Prior medication/therapy for DLBCL
Yes
|
91.5 Percentage of participants
n=5 Participants
|
|
Prior medication/therapy for DLBCL (Transplant)
No
|
86.4 Percentage of participants
n=5 Participants
|
|
Prior medication/therapy for DLBCL (Transplant)
Yes
|
13.6 Percentage of participants
n=5 Participants
|
|
Prior treatment for DLBCL
No
|
0.0 Percentage of participants
n=5 Participants
|
|
Prior treatment for DLBCL
Yes
|
100.0 Percentage of participants
n=5 Participants
|
|
Number of regimens
1
|
64.4 Percentage of participants
n=5 Participants
|
|
Number of regimens
2
|
22.0 Percentage of participants
n=5 Participants
|
|
Number of regimens
3
|
13.6 Percentage of participants
n=5 Participants
|
|
P.S.(performance status)[the Eastern Cooperative Oncology Group (ECOG) criteria]
0
|
66.1 Percentage of Participants
n=5 Participants
|
|
P.S.(performance status)[the Eastern Cooperative Oncology Group (ECOG) criteria]
1
|
33.9 Percentage of Participants
n=5 Participants
|
|
Tumor diameter
<5 cm
|
71.2 Percentage of Participants
n=5 Participants
|
|
Tumor diameter
≥5 cm
|
28.8 Percentage of Participants
n=5 Participants
|
|
Tumor diameter
<7 cm
|
86.4 Percentage of Participants
n=5 Participants
|
|
Tumor diameter
≥7 cm
|
13.6 Percentage of Participants
n=5 Participants
|
|
lactate dehydrogenase (LDH)
Within normal range
|
44.1 Percentage of Participants
n=5 Participants
|
|
lactate dehydrogenase (LDH)
Elevated
|
55.9 Percentage of Participants
n=5 Participants
|
|
LDH
<240 IU/L
|
39.0 Percentage of Participants
n=5 Participants
|
|
LDH
≥240 IU/L
|
61.0 Percentage of Participants
n=5 Participants
|
|
Site of disease
<4 nodular sites
|
47.5 Percentage of Participants
n=5 Participants
|
|
Site of disease
≥4 nodular sites
|
52.5 Percentage of Participants
n=5 Participants
|
|
Site of disease
<2 extranodular sites
|
93.2 Percentage of Participants
n=5 Participants
|
|
Site of disease
≥4 extranodular sites
|
6.8 Percentage of Participants
n=5 Participants
|
|
Bone marrow involvement
Positive
|
3.4 Percentage of Participants
n=5 Participants
|
|
Bone marrow involvement
Negative
|
94.9 Percentage of Participants
n=5 Participants
|
|
Bone marrow involvement
Indeterminate
|
0.0 Percentage of Participants
n=5 Participants
|
|
Bone marrow involvement
Unknown
|
1.7 Percentage of Participants
n=5 Participants
|
|
Response to prior treatment
Responder
|
100.0 Percentage of Participants
n=5 Participants
|
|
Response to prior treatment
Non-Responder
|
0.0 Percentage of Participants
n=5 Participants
|
|
Response to prior treatment
Unknown
|
0.0 Percentage of Participants
n=5 Participants
|
|
Time from prior treatment
<12 months
|
15.3 Percentage of Participants
n=5 Participants
|
|
Time from prior treatment
≥12 months
|
49.2 Percentage of Participants
n=5 Participants
|
|
Time from prior treatment
Unknown
|
0.0 Percentage of Participants
n=5 Participants
|
|
International Prognostic Index risk category
Low (score=0-1)
|
33.9 Percentage of Participants
n=5 Participants
|
|
International Prognostic Index risk category
Low-Intermediate (score=2)
|
35.6 Percentage of Participants
n=5 Participants
|
|
International Prognostic Index risk category
High-Intermediate (score=3)
|
23.6 Percentage of Participants
n=5 Participants
|
|
International Prognostic Index risk category
High(score=4-5)
|
6.8 Percentage of Participants
n=5 Participants
|
|
International Prognostic Index risk category
Unknown
|
0.0 Percentage of Participants
n=5 Participants
|
|
International Prognostic Index risk category
Low-Intermediate (score<3)
|
69.5 Percentage of Participants
n=5 Participants
|
|
International Prognostic Index risk category
High-Intermediate (score≥3)
|
30.5 Percentage of Participants
n=5 Participants
|
|
Height
|
158.25 cm
STANDARD_DEVIATION 8.59 • n=5 Participants
|
|
Weight
|
57.64 kg
STANDARD_DEVIATION 12.85 • n=5 Participants
|
|
Body Surface Area（BSA）
|
1.537 m^2
STANDARD_DEVIATION 0.184 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to 30 weeksCR: Disappearance of all evidence of disease. PR: Regression of measurable disease and no new sites. For the criteria for CR, See Outcome measure 2 description. The criteria for PR is as below. Nodal Masses: more than 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes 1. FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site 2. Variably FDG-avid or PET negative; regression on CT Spleen, Liver: more than 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified
Outcome measures
| Measure |
SyB L-0501
n=59 Participants
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
|
62.7 Percentage of Participants
Interval 49.1 to 75.0
|
SECONDARY outcome
Timeframe: up to 30 weeksThe criteria for CR is as below Nodal Masses: 1. fluorodeoxy glucose (FDG)-avid or positron emission tomography (PET) positive prior to therapy; mass of any size permitted if PET negative 2. Variably FDG-avid or PET negative; regression to normal size on computed tomography (CT) Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative
Outcome measures
| Measure |
SyB L-0501
n=59 Participants
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
|
37.3 Percentage of participants
Interval 25.0 to 50.9
|
SECONDARY outcome
Timeframe: up to 30 weeksPFS = day of the first PFS event - day of start of study treatment + 1 The definitions of PFS event are as below. 1. PD according to overall response on the basis of Revised Response Criteria for Malignant Lymphoma PD: Any new lesion or increase by ≥50% of previously involved sites from nadir. Nodal masses; Appearance of a new lesion(s) \>1.5 cm in any axis, ≥50% increase in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node \>1 cm in short axis. Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. Spleen, Liver; ≥50% increase from nadir in the SPD of any previous lesions. Bone marrow; New or recurrent involvement 2. Disease progression during treatment period 3. Disease progression during follow up period 4. Start of treatment of new lesion 5. Occurrence of other multiple malignant tumors 6. Death
Outcome measures
| Measure |
SyB L-0501
n=59 Participants
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
Progression Free Survival (PFS)
|
200.0 Days
Interval 109.0 to 410.0
|
SECONDARY outcome
Timeframe: up to 30 weeksOutcome measures
| Measure |
SyB L-0501
n=59 Participants
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
Number of Subjects With Adverse Event
Subjects with adverse event
|
59 Participants
|
|
Number of Subjects With Adverse Event
Subjects with serious adverse event
|
14 Participants
|
SECONDARY outcome
Timeframe: up to 30 weeksOutcome measures
| Measure |
SyB L-0501
n=59 Participants
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
Number of Adverse Events
Adverse events
|
1848 Events
|
|
Number of Adverse Events
Serious adverse events
|
23 Events
|
SECONDARY outcome
Timeframe: up to 30 weeksAbnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild grade 2 : moderate grade 3 : severe grade 4 : life threatening or disabling grade 5 : death related to adverse event
Outcome measures
| Measure |
SyB L-0501
n=59 Participants
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
Subjects with grade 3 abnormality
|
2 Participants
|
|
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
Subjects with grade 4 abnormality
|
54 Participants
|
SECONDARY outcome
Timeframe: up to 30 weeksOutcome measures
| Measure |
SyB L-0501
n=59 Participants
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
Number of Subjects With Grade ≥3 Physical Examination Finding
Subjects with grade 3 Physical Findings
|
1 Participants
|
|
Number of Subjects With Grade ≥3 Physical Examination Finding
Subjects with grade 4 Physical Findings
|
22 Participants
|
SECONDARY outcome
Timeframe: up to 30 weeksOutcome measures
| Measure |
SyB L-0501
n=59 Participants
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
Concomitant Medication Usage
concomitant medications for adverse events
|
58 Participants
|
|
Concomitant Medication Usage
concomitant medications for complications
|
50 Participants
|
|
Concomitant Medication Usage
concomitant medications for supportive therapy
|
59 Participants
|
|
Concomitant Medication Usage
concomitant medications for other reasons
|
59 Participants
|
SECONDARY outcome
Timeframe: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycleOutcome measures
| Measure |
SyB L-0501
n=10 Participants
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan
|
8365.82 ng/mL
Standard Deviation 3522.73
|
SECONDARY outcome
Timeframe: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycleOutcome measures
| Measure |
SyB L-0501
n=10 Participants
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan
|
1.0 hour
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycleOutcome measures
| Measure |
SyB L-0501
n=10 Participants
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan
|
10394.39 ng・h/mL
Standard Deviation 5368.77
|
SECONDARY outcome
Timeframe: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycleOutcome measures
| Measure |
SyB L-0501
n=10 Participants
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan
|
0.39 hour
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycleOutcome measures
| Measure |
SyB L-0501
n=4 Participants
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea
|
8095.99 ng/mL
Standard Deviation 4339.74
|
SECONDARY outcome
Timeframe: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycleOutcome measures
| Measure |
SyB L-0501
n=4 Participants
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea
|
0.9 hour
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycleOutcome measures
| Measure |
SyB L-0501
n=4 Participants
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea
|
9218.56 ng・h/mL
Standard Deviation 6696.81
|
SECONDARY outcome
Timeframe: Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycleOutcome measures
| Measure |
SyB L-0501
n=4 Participants
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea
|
0.48 hour
Standard Deviation 0.18
|
Adverse Events
SyB L-0501
Serious events: 14 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SyB L-0501
n=59 participants at risk
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
1/59 • up to 30 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
1/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Constipation
|
3.4%
2/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/59 • up to 30 weeks
|
|
General disorders
Asthenia
|
3.4%
2/59 • up to 30 weeks
|
|
General disorders
Death
|
1.7%
1/59 • up to 30 weeks
|
|
General disorders
Mucosal inflammation
|
1.7%
1/59 • up to 30 weeks
|
|
Infections and infestations
Cytomegalovirus infection
|
5.1%
3/59 • up to 30 weeks
|
|
Infections and infestations
Infection
|
1.7%
1/59 • up to 30 weeks
|
|
Infections and infestations
Pneumonia
|
5.1%
3/59 • up to 30 weeks
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
1.7%
1/59 • up to 30 weeks
|
|
Infections and infestations
Gastric cancer
|
1.7%
1/59 • up to 30 weeks
|
|
Renal and urinary disorders
Urinary retention
|
1.7%
1/59 • up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/59 • up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/59 • up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.7%
1/59 • up to 30 weeks
|
|
Vascular disorders
Shock haemorrhagic
|
1.7%
1/59 • up to 30 weeks
|
Other adverse events
| Measure |
SyB L-0501
n=59 participants at risk
SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.8%
30/59 • up to 30 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.8%
4/59 • up to 30 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.7%
1/59 • up to 30 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
20.3%
12/59 • up to 30 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
23.7%
14/59 • up to 30 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.5%
18/59 • up to 30 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
27.1%
16/59 • up to 30 weeks
|
|
Cardiac disorders
Arrhythmia supraventricular
|
1.7%
1/59 • up to 30 weeks
|
|
Cardiac disorders
Palpitations
|
1.7%
1/59 • up to 30 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
1.7%
1/59 • up to 30 weeks
|
|
Cardiac disorders
Supraventricular extrasystoles
|
1.7%
1/59 • up to 30 weeks
|
|
Eye disorders
Conjunctival haemorrhage
|
1.7%
1/59 • up to 30 weeks
|
|
Eye disorders
Lacrimation increased
|
1.7%
1/59 • up to 30 weeks
|
|
Eye disorders
Vision blurred
|
1.7%
1/59 • up to 30 weeks
|
|
Eye disorders
Vitreous floaters
|
1.7%
1/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.5%
5/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
2/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
1/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Anal ulcer
|
1.7%
1/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Cheilitis
|
1.7%
1/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Constipation
|
49.2%
29/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
8/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
1/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Enterocolitis
|
1.7%
1/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Glossitis
|
1.7%
1/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Nausea
|
33.9%
20/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Oral discomfort
|
1.7%
1/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Oral pain
|
1.7%
1/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Periodontitis
|
1.7%
1/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
20.3%
12/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Vomiting
|
10.2%
6/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.7%
1/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Oral mucosa erosion
|
1.7%
1/59 • up to 30 weeks
|
|
General disorders
Application site reaction
|
1.7%
1/59 • up to 30 weeks
|
|
General disorders
Asthenia
|
11.9%
7/59 • up to 30 weeks
|
|
General disorders
Chest discomfort
|
1.7%
1/59 • up to 30 weeks
|
|
General disorders
Chills
|
1.7%
1/59 • up to 30 weeks
|
|
General disorders
Face oedema
|
3.4%
2/59 • up to 30 weeks
|
|
General disorders
Fatigue
|
22.0%
13/59 • up to 30 weeks
|
|
General disorders
Feeling hot
|
5.1%
3/59 • up to 30 weeks
|
|
General disorders
Generalised oedema
|
1.7%
1/59 • up to 30 weeks
|
|
General disorders
Influenza like illness
|
1.7%
1/59 • up to 30 weeks
|
|
General disorders
Injection site erythema
|
1.7%
1/59 • up to 30 weeks
|
|
General disorders
Injection site pain
|
1.7%
1/59 • up to 30 weeks
|
|
General disorders
Injection site phlebitis
|
1.7%
1/59 • up to 30 weeks
|
|
General disorders
Injection site reaction
|
5.1%
3/59 • up to 30 weeks
|
|
General disorders
Malaise
|
23.7%
14/59 • up to 30 weeks
|
|
General disorders
Mucosal inflammation
|
6.8%
4/59 • up to 30 weeks
|
|
General disorders
Multi-organ failure
|
1.7%
1/59 • up to 30 weeks
|
|
General disorders
Oedema
|
6.8%
4/59 • up to 30 weeks
|
|
General disorders
Oedema peripheral
|
10.2%
6/59 • up to 30 weeks
|
|
General disorders
Pyrexia
|
25.4%
15/59 • up to 30 weeks
|
|
General disorders
Infusion site reaction
|
1.7%
1/59 • up to 30 weeks
|
|
General disorders
Inflammation
|
1.7%
1/59 • up to 30 weeks
|
|
Hepatobiliary disorders
Jaundice
|
1.7%
1/59 • up to 30 weeks
|
|
Hepatobiliary disorders
Liver disorder
|
1.7%
1/59 • up to 30 weeks
|
|
Hepatobiliary disorders
Liver injury
|
1.7%
1/59 • up to 30 weeks
|
|
Immune system disorders
Hypersensitivity
|
1.7%
1/59 • up to 30 weeks
|
|
Infections and infestations
Bronchitis
|
1.7%
1/59 • up to 30 weeks
|
|
Infections and infestations
Cystitis
|
1.7%
1/59 • up to 30 weeks
|
|
Infections and infestations
Cytomegalovirus infection
|
3.4%
2/59 • up to 30 weeks
|
|
Infections and infestations
Gastrointestinal infection
|
1.7%
1/59 • up to 30 weeks
|
|
Infections and infestations
Herpes zoster
|
6.8%
4/59 • up to 30 weeks
|
|
Infections and infestations
Infection
|
3.4%
2/59 • up to 30 weeks
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
4/59 • up to 30 weeks
|
|
Infections and infestations
Oral candidiasis
|
5.1%
3/59 • up to 30 weeks
|
|
Infections and infestations
Sinusitis
|
1.7%
1/59 • up to 30 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
3/59 • up to 30 weeks
|
|
Infections and infestations
Urinary tract infection
|
3.4%
2/59 • up to 30 weeks
|
|
Infections and infestations
Enterocolitis infectious
|
1.7%
1/59 • up to 30 weeks
|
|
Infections and infestations
Oral herpes
|
6.8%
4/59 • up to 30 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
1/59 • up to 30 weeks
|
|
Injury, poisoning and procedural complications
Tooth injury
|
1.7%
1/59 • up to 30 weeks
|
|
Injury, poisoning and procedural complications
Open wound
|
1.7%
1/59 • up to 30 weeks
|
|
Investigations
Alanine aminotransferase increased
|
32.2%
19/59 • up to 30 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
37.3%
22/59 • up to 30 weeks
|
|
Investigations
Blood albumin decreased
|
1.7%
1/59 • up to 30 weeks
|
|
Investigations
Blood bilirubin increased
|
3.4%
2/59 • up to 30 weeks
|
|
Investigations
Blood chloride increased
|
1.7%
1/59 • up to 30 weeks
|
|
Investigations
Blood creatinine increased
|
13.6%
8/59 • up to 30 weeks
|
|
Investigations
Blood immunoglobulin A decreased
|
40.7%
24/59 • up to 30 weeks
|
|
Investigations
Blood immunoglobulin G decreased
|
44.1%
26/59 • up to 30 weeks
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.9%
20/59 • up to 30 weeks
|
|
Investigations
Blood potassium increased
|
3.4%
2/59 • up to 30 weeks
|
|
Investigations
Blood urea decreased
|
6.8%
4/59 • up to 30 weeks
|
|
Investigations
Blood urea increased
|
10.2%
6/59 • up to 30 weeks
|
|
Investigations
Blood uric acid decreased
|
1.7%
1/59 • up to 30 weeks
|
|
Investigations
Blood uric acid increased
|
1.7%
1/59 • up to 30 weeks
|
|
Investigations
C-reactive protein increased
|
39.0%
23/59 • up to 30 weeks
|
|
Investigations
CD4 lymphocytes decreased
|
69.5%
41/59 • up to 30 weeks
|
|
Investigations
Eosinophil count increased
|
1.7%
1/59 • up to 30 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
27.1%
16/59 • up to 30 weeks
|
|
Investigations
Glucose urine present
|
5.1%
3/59 • up to 30 weeks
|
|
Investigations
Glycosylated haemoglobin increased
|
1.7%
1/59 • up to 30 weeks
|
|
Investigations
Blood urine present
|
1.7%
1/59 • up to 30 weeks
|
|
Investigations
Haemoglobin decreased
|
3.4%
2/59 • up to 30 weeks
|
|
Investigations
Liver function test abnormal
|
3.4%
2/59 • up to 30 weeks
|
|
Investigations
Lymphocyte count decreased
|
55.9%
33/59 • up to 30 weeks
|
|
Investigations
Neutrophil count decreased
|
57.6%
34/59 • up to 30 weeks
|
|
Investigations
Platelet count decreased
|
44.1%
26/59 • up to 30 weeks
|
|
Investigations
Protein total decreased
|
27.1%
16/59 • up to 30 weeks
|
|
Investigations
Red blood cell count decreased
|
8.5%
5/59 • up to 30 weeks
|
|
Investigations
Weight decreased
|
18.6%
11/59 • up to 30 weeks
|
|
Investigations
Weight increased
|
6.8%
4/59 • up to 30 weeks
|
|
Investigations
White blood cell count decreased
|
62.7%
37/59 • up to 30 weeks
|
|
Investigations
White blood cell count increased
|
45.8%
27/59 • up to 30 weeks
|
|
Investigations
Blood bilirubin decreased
|
1.7%
1/59 • up to 30 weeks
|
|
Investigations
Platelet count increased
|
1.7%
1/59 • up to 30 weeks
|
|
Investigations
Basophil percentage increased
|
1.7%
1/59 • up to 30 weeks
|
|
Investigations
Eosinophil percentage decreased
|
1.7%
1/59 • up to 30 weeks
|
|
Investigations
Eosinophil percentage increased
|
5.1%
3/59 • up to 30 weeks
|
|
Investigations
Monocyte percentage decreased
|
3.4%
2/59 • up to 30 weeks
|
|
Investigations
Monocyte percentage increased
|
3.4%
2/59 • up to 30 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
18.6%
11/59 • up to 30 weeks
|
|
Investigations
Hepatitis B virus test positive
|
1.7%
1/59 • up to 30 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/59 • up to 30 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.1%
3/59 • up to 30 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
13.6%
8/59 • up to 30 weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.4%
2/59 • up to 30 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
22.0%
13/59 • up to 30 weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.8%
4/59 • up to 30 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.4%
2/59 • up to 30 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.8%
4/59 • up to 30 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.9%
7/59 • up to 30 weeks
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
1.7%
1/59 • up to 30 weeks
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
3.4%
2/59 • up to 30 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.9%
20/59 • up to 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/59 • up to 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
2/59 • up to 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.4%
2/59 • up to 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
2/59 • up to 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.7%
1/59 • up to 30 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.7%
1/59 • up to 30 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
1.7%
1/59 • up to 30 weeks
|
|
Nervous system disorders
Burning sensation
|
1.7%
1/59 • up to 30 weeks
|
|
Nervous system disorders
Dizziness
|
6.8%
4/59 • up to 30 weeks
|
|
Nervous system disorders
Dysgeusia
|
10.2%
6/59 • up to 30 weeks
|
|
Nervous system disorders
Headache
|
16.9%
10/59 • up to 30 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
1.7%
1/59 • up to 30 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.7%
1/59 • up to 30 weeks
|
|
Nervous system disorders
Tremor
|
1.7%
1/59 • up to 30 weeks
|
|
Psychiatric disorders
Delirium
|
5.1%
3/59 • up to 30 weeks
|
|
Psychiatric disorders
Insomnia
|
23.7%
14/59 • up to 30 weeks
|
|
Psychiatric disorders
Major depression
|
1.7%
1/59 • up to 30 weeks
|
|
Renal and urinary disorders
Haematuria
|
3.4%
2/59 • up to 30 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
3.4%
2/59 • up to 30 weeks
|
|
Renal and urinary disorders
Proteinuria
|
6.8%
4/59 • up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.7%
1/59 • up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
5/59 • up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.1%
3/59 • up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.7%
1/59 • up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.2%
6/59 • up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.7%
1/59 • up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.8%
4/59 • up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
1.7%
1/59 • up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.1%
3/59 • up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
1.7%
1/59 • up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.4%
2/59 • up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.4%
2/59 • up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
1.7%
1/59 • up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
1.7%
1/59 • up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.4%
2/59 • up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.7%
1/59 • up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.7%
1/59 • up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
1.7%
1/59 • up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.7%
1/59 • up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.8%
4/59 • up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.9%
10/59 • up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.5%
5/59 • up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
1.7%
1/59 • up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
1.7%
1/59 • up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.4%
2/59 • up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Photodermatosis
|
1.7%
1/59 • up to 30 weeks
|
|
Vascular disorders
Flushing
|
1.7%
1/59 • up to 30 weeks
|
|
Vascular disorders
Hypertension
|
1.7%
1/59 • up to 30 weeks
|
|
Vascular disorders
Hypotension
|
6.8%
4/59 • up to 30 weeks
|
|
Vascular disorders
Phlebitis
|
1.7%
1/59 • up to 30 weeks
|
|
Vascular disorders
Vasculitis
|
3.4%
2/59 • up to 30 weeks
|
|
Vascular disorders
Haemorrhage
|
1.7%
1/59 • up to 30 weeks
|
|
Vascular disorders
Angiopathy
|
5.1%
3/59 • up to 30 weeks
|
|
Vascular disorders
Hot flush
|
8.5%
5/59 • up to 30 weeks
|
|
Gastrointestinal disorders
Thirst
|
1.7%
1/59 • up to 30 weeks
|
|
Investigations
Blood immunoglobulin M decreased
|
42.4%
25/59 • up to 30 weeks
|
|
Investigations
Neutrophil count increased
|
37.3%
22/59 • up to 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.1%
3/59 • up to 30 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place