The purpose of this study is to determine the efficacy of SyB L-0501 in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.
Primary Objective is to determine the efficacy, as measured by overall response rate on the basis of Revised Response Criteria for Malignant Lymphoma, of SyB L-0501 at 120 mg/m\^2/day on day2 and 3 in combination with rituximab at 375 mg/m\^2 on day 1 of each 21-day cycle in patients with relapsed/refractory diffuse large B-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
The administration of SyB L-0501 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. SyB L-0501 60 mg/m\^2, 90 mg/m\^2 or 120 mg/m\^2/day on Day 2 and Day 3 will be followed by 18 days of observation.
The administration of rituximab 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.
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Akita, Akita, Japan
The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
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
Time frame: up to 30 weeks
The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
The 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
Time frame: up to 30 weeks
Progression Free Survival (PFS)
PFS = 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
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Unnamed facility
Matsuyama, Ehime, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Kurume, Fukuoka, Japan
Unnamed facility
Maebashi, Gunma, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Kanazawa, Ishikawa-ken, Japan
Unnamed facility
Kagoshima, Kagoshima-ken, Japan
Unnamed facility
Isehara, Kanagawa, Japan
...and 15 more locations
Time frame: up to 30 weeks
Number of Subjects With Adverse Event
Time frame: up to 30 weeks
Number of Adverse Events
Time frame: up to 30 weeks
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
Abnormalities 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
Time frame: up to 30 weeks
Number of Subjects With Grade ≥3 Physical Examination Finding
Time frame: up to 30 weeks
Concomitant Medication Usage
Time frame: up to 30 weeks
The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan
Time frame: 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 cycle
The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan
Time frame: 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 cycle
The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan
Time frame: 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 cycle
The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan
Time frame: 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 cycle
The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea
Time frame: 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 cycle
The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea
Time frame: 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 cycle
The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea
Time frame: 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 cycle
The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea
Time frame: 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 cycle