Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the efficacy and safety of SyB L-0501 (two-day consecutive 90 mg/m2/day IV drip infusions) in combination with rituximab (375 mg/m2 IV drip infusion) on untreated, low-grade B cell non-Hodgkin's lymphoma and mantle cell lymphoma where hematopoietic stem cell transplantation is not indicated.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SyB L-0501＋rituximab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SyB L-0501 | Drug | A dose of 90 mg/m^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC) | The criteria for CR and CRu based on IWRC are shown below. CR: Fulfills all of the following
CRu: Fulfills all of the following
| Up to 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (Antitumor Effect: PR or Better) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC) | The criteria for PR based on IWRC are shown below. PR: SPD regressed > 50% | Up to 30 weeks |
| Complete Response Rate (CR) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC) |
Not provided
Inclusion Criteria:
Patients who are histopathologically confirmed to have the following cluster of differentiation 20 (CD20) positive low-grade B cell non-Hodgkin's lymphoma or mantle cell lymphoma by lymph node biopsy or evaluable tissue biopsy within 6 months before the registration WHO Classification of Tumors (fourth edition):
Patients with a measurable lesion ( > 1.5 cm in major axis on CT)
Patients without a medical history
Patients with at least 1 of the following clinical symptoms or signs (excluding mantle cell lymphoma):
Bulky disease measuring > 7 cm in major axis on CT (excluding spleen)
B symptoms
Elevated serum LDH or beta 2 microglobulin
Three or more regional lymph nodes of > 3 cm in major axis on CT
Symptomatic splenomegaly
Intracranial pressure
Pleural effusion/ascites retention
Patients expected to live for at least 3 months
Patients aged between 20 and 79 years (at the time of registration)
Patients whose Eastern Cooperative Oncology Group (ECOG) performance status (P.S.) is 0～2
Patients with adequately maintained major organ function (bone marrow, heart, lungs, liver, kidneys)
Patients whose informed consent has been obtained in person
Exclusion Criteria:
Patients who fall under any one of the following criteria are to be excluded
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Nagoya | Aichi-ken | Japan | |||
| Research site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Low-grade B-cell Non-Hodgkin's Lymphoma | Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma. |
| FG001 | Mantle Cell Lymphoma |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| rituximab | Drug | A dose of 375 mg/m^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0. |
|
The criteria for CR based on the Revised RC are shown below. Definition: Disappearance of all evidence of disease Nodal Masses:
Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative. |
| Up to 30 weeks |
| Overall Response Rate (PR or Better) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC) | The criteria for PR based on the Revised RC are shown below. Definition: Regression of measurable disease and no new sites Nodal Masses: 50% or more decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes
Spleen, Liver: 50% or more 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. | Up to 30 weeks |
| Complete Response Rate Based on WHO Handbook for Reporting Results of Cancer Treatment (1979) | The criteria for Complete response based on WHO Handbook for Reporting Results of Cancer Treatment (1979) are shown below. Measurable disease: The disappearance of all known disease, determined by 2 observations not less than 4 weeks apart. Unmeasurable disease: Complete disappearance of all known disease for at least 4 weeks. Bone metastases: Complete disappearance of all lesions on X-ray or scan for at least 4 weeks. | Up to 30 weeks |
| Overall Response Rate (PR or Better) Based on "WHO Handbook for Reporting Results of Cancer Treatment (1979)" | The criteria for Overall response rate (PR or better) based on "WHO Handbook for Reporting Results of Cancer Treatment (1979)" are shown below. Definition of PR: Measurable disease: 50% or more decrease in total tumor size of the lesions which have been measured to determine the effect of therapy by 2 observations not less than 4 weeks apart. In addition there can be no appearance of new lesions or progression of any lesion. Unmeasurable disease: Estimated decrease in tumor size of 50% or more for at least 4 weeks. Bone metastases: Partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for at least 4 weeks. | Up to 30 weeks |
| Progression-Free Survival (PFS) | PFS is the period from registration date to the earliest onset date of any progression event calculated using the Kaplan-Meier estimator. The median and the 95% confidence interval (CI) were calculated using Greenwood's formula. Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause. The date of progression was determined based on overall response assessed using IWRC, Revised RC, and WHO, and assessment by the primary physicians (excluding overall response). | Up to 30 weeks |
| Duration of Response (DOR) | DOR is the period from the date of achieving CR, CRu or PR in the responders to the earliest onset date of any progression events calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula. The date of achieving CR, CRu or PR was determined based on the overall response assessed using IWRC. The date of progression was determined based on overall response assessed using IWRC, Revised RC and WHO, and assessment by the primary physicians (excluding overall response). Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause. | Up to 30 weeks |
| Overall Survival (OS) | Death due to any given cause was defined as an event. OS was calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula. | Up to 30 weeks |
| Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event | Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA) Ver.16.1. | up to 30 weeks |
| Laboratory Test Abnormalities (Biochemical Tests) | Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE | up to 30 weeks |
| Laboratory Test Abnormalities (Hematology Tests) | Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE | up to 30 weeks |
| Kashiwa |
| Chiba |
| Japan |
| Research site | Fukuoka | Fukuoka | Japan |
| Research site | Sapporo | Hokkaido | Japan |
| Research site | Kagoshima | Kagoshima-ken | Japan |
| Research site | Isehara | Kanagawa | Japan |
| Research site | Kyoto | Kyoto | Japan |
| Research site | Sendai | Miyagi | Japan |
| Research site | Nagasaki | Nagasaki | Japan |
| Research site | Moriguchi | Osaka | Japan |
| Research site | Izumo | Shimane | Japan |
| Research site | Hamamatsu | Shizuoka | Japan |
| Research site | Utsunomiya | Tochigi | Japan |
| Research site | Tokyo | Tokyo | Japan |
Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma.
| COMPLETED |
|
| NOT COMPLETED |
|
Of the 70 subjects enrolled, one who did not receive the investigational product was excluded. Therefore, the total number of Baseline Participants is 69.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Low-grade B-cell Non-Hodgkin's Lymphoma | Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma |
| BG001 | Mantle Cell Lymphoma | Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Performance status (ECOG scale) | The criteria of Eastern Cooperative Oncology Group (ECOG) performance status are shown below. 0: Symptoms are absent, no restrictions on lifestyle
| Number | participants |
| ||||||||||||||||||
| Diagnosis (WHO classification) | Number | participants |
| |||||||||||||||||||
| Clinical stage (Ann Arbor staging classification) | The criteria of Ann Arbor staging classification are shown below. I: Invasion of 1 lymph node region II: Invasion of 2 or more lymphatic regions confined to 1 side of the diaphragm III: Invasion of multiple lymph node regions spanning above and below the diaphragm IV: Diffuse invasion to an organ or area other than 1 or multiple lymphatic tissues, regardless of the presence/absence of lymph node lesions. | Number | participants |
| ||||||||||||||||||
| Number of lymph node regions | Number | participants |
| |||||||||||||||||||
| Number of extranodal lesions | Number | participants |
| |||||||||||||||||||
| Tumor diameter (1) | Number | participants |
| |||||||||||||||||||
| Tumor diameter (2) | Number | participants |
| |||||||||||||||||||
| Lactate dehydrogenase (LDH) | Number | participants |
| |||||||||||||||||||
| Beta 2 microglobulin | Number | participants |
| |||||||||||||||||||
| C-reactive protein (CRP) | Number | participants |
| |||||||||||||||||||
| Hepatomegaly | Number | participants |
| |||||||||||||||||||
| Splenomegaly | Number | participants |
| |||||||||||||||||||
| Enlarged kidney | Number | participants |
| |||||||||||||||||||
| B symptoms (fever) | Number | participants |
| |||||||||||||||||||
| B symptoms (night sweats) | Number | participants |
| |||||||||||||||||||
| B symptoms (weight loss) | Number | participants |
| |||||||||||||||||||
| Symptomatic splenomegaly | Number | participants |
| |||||||||||||||||||
| Pressure symptoms | Number | participants |
| |||||||||||||||||||
| Pleural effusion/ascites retention | Number | participants |
| |||||||||||||||||||
| Bone marrow invasion | Number | participants |
| |||||||||||||||||||
| Chromosome abnormality | Number | participants |
| |||||||||||||||||||
| Previous medical history | Number | participants |
| |||||||||||||||||||
| Concomitant disease | Number | participants |
| |||||||||||||||||||
| FLIPI risk category | The criteria for Follicular Lymphoma International Prognostic Index (FLIPI) are shown below.
| Number | participants |
| ||||||||||||||||||
| IPI risk category | The criteria for International Prognostic Index are shown below.
| Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC) | The criteria for CR and CRu based on IWRC are shown below. CR: Fulfills all of the following
CRu: Fulfills all of the following
| Posted | Number | percentage of participants | Up to 30 weeks |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (Antitumor Effect: PR or Better) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC) | The criteria for PR based on IWRC are shown below. PR: SPD regressed > 50% | Posted | Number | percentage of participants | Up to 30 weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate (CR) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC) | The criteria for CR based on the Revised RC are shown below. Definition: Disappearance of all evidence of disease Nodal Masses:
Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative. | Posted | Number | percentage of participants | Up to 30 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (PR or Better) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC) | The criteria for PR based on the Revised RC are shown below. Definition: Regression of measurable disease and no new sites Nodal Masses: 50% or more decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes
Spleen, Liver: 50% or more 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. | Posted | Number | percentage of participants | Up to 30 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate Based on WHO Handbook for Reporting Results of Cancer Treatment (1979) | The criteria for Complete response based on WHO Handbook for Reporting Results of Cancer Treatment (1979) are shown below. Measurable disease: The disappearance of all known disease, determined by 2 observations not less than 4 weeks apart. Unmeasurable disease: Complete disappearance of all known disease for at least 4 weeks. Bone metastases: Complete disappearance of all lesions on X-ray or scan for at least 4 weeks. | Posted | Number | percentage of participants | Up to 30 weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (PR or Better) Based on "WHO Handbook for Reporting Results of Cancer Treatment (1979)" | The criteria for Overall response rate (PR or better) based on "WHO Handbook for Reporting Results of Cancer Treatment (1979)" are shown below. Definition of PR: Measurable disease: 50% or more decrease in total tumor size of the lesions which have been measured to determine the effect of therapy by 2 observations not less than 4 weeks apart. In addition there can be no appearance of new lesions or progression of any lesion. Unmeasurable disease: Estimated decrease in tumor size of 50% or more for at least 4 weeks. Bone metastases: Partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for at least 4 weeks. | Posted | Number | percentage of participants | Up to 30 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | PFS is the period from registration date to the earliest onset date of any progression event calculated using the Kaplan-Meier estimator. The median and the 95% confidence interval (CI) were calculated using Greenwood's formula. Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause. The date of progression was determined based on overall response assessed using IWRC, Revised RC, and WHO, and assessment by the primary physicians (excluding overall response). | Posted | Median | 95% Confidence Interval | days | Up to 30 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR is the period from the date of achieving CR, CRu or PR in the responders to the earliest onset date of any progression events calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula. The date of achieving CR, CRu or PR was determined based on the overall response assessed using IWRC. The date of progression was determined based on overall response assessed using IWRC, Revised RC and WHO, and assessment by the primary physicians (excluding overall response). Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause. | Posted | Median | 95% Confidence Interval | days | Up to 30 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Death due to any given cause was defined as an event. OS was calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula. | Posted | Median | 95% Confidence Interval | days | Up to 30 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event | Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA) Ver.16.1. | Posted | Number | participants | up to 30 weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Laboratory Test Abnormalities (Biochemical Tests) | Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE | Posted | Number | participants | up to 30 weeks |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Laboratory Test Abnormalities (Hematology Tests) | Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE | Posted | Number | participants | up to 30 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SyB L-0501＋Rituximab | Drug: SyB L-0501 A dose of 90 mg/m^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. Drug: rituximab A dose of 375 mg/m^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0. | 9 | 69 | 69 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 |
| ||
| tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 |
| ||
| pneumonia cytomegaloviral | Infections and infestations | MedDRA 16.1 |
| ||
| dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| cytogenetic abnormality | Congenital, familial and genetic disorders | MedDRA 16.1 |
| ||
| atrial tachycardia | Cardiac disorders | MedDRA 16.1 |
| ||
| pyrexia | General disorders | MedDRA 16.1 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 |
| ||
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 16.1 |
| ||
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 16.1 |
| ||
| Cardiac failure | Cardiac disorders | MedDRA 16.1 |
| ||
| Sinus bradycardia | Cardiac disorders | MedDRA 16.1 |
| ||
| Ventricular arrhythmia | Cardiac disorders | MedDRA 16.1 |
| ||
| Tinnitus | Ear and labyrinth disorders | MedDRA 16.1 |
| ||
| Vertigo | Ear and labyrinth disorders | MedDRA 16.1 |
| ||
| External ear inflammation | Ear and labyrinth disorders | MedDRA 16.1 |
| ||
| Steroid withdrawal syndrome | Endocrine disorders | MedDRA 16.1 |
| ||
| Asthenopia | Eye disorders | MedDRA 16.1 |
| ||
| Conjunctivitis | Eye disorders | MedDRA 16.1 |
| ||
| Dry eye | Eye disorders | MedDRA 16.1 |
| ||
| Erythema of eyelid | Eye disorders | MedDRA 16.1 |
| ||
| Scintillating scotoma | Eye disorders | MedDRA 16.1 |
| ||
| Trichiasis | Eye disorders | MedDRA 16.1 |
| ||
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Anal fissure | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Cheilitis | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Constipation | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Dental caries | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Gastritis | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Nausea | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Oesophageal pain | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Proctalgia | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Stomatitis | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 |
| ||
| Chest discomfort | General disorders | MedDRA 16.1 |
| ||
| Chest pain | General disorders | MedDRA 16.1 |
| ||
| Chills | General disorders | MedDRA 16.1 |
| ||
| Fatigue | General disorders | MedDRA 16.1 |
| ||
| Injection site bruising | General disorders | MedDRA 16.1 |
| ||
| Injection site induration | General disorders | MedDRA 16.1 |
| ||
| Injection site pain | General disorders | MedDRA 16.1 |
| ||
| Injection site phlebitis | General disorders | MedDRA 16.1 |
| ||
| Injection site reaction | General disorders | MedDRA 16.1 |
| ||
| Local swelling | General disorders | MedDRA 16.1 |
| ||
| Malaise | General disorders | MedDRA 16.1 |
| ||
| Oedema | General disorders | MedDRA 16.1 |
| ||
| Oedema peripheral | General disorders | MedDRA 16.1 |
| ||
| Pain | General disorders | MedDRA 16.1 |
| ||
| Pyrexia | General disorders | MedDRA 16.1 |
| ||
| Thirst | General disorders | MedDRA 16.1 |
| ||
| Injection site swelling | General disorders | MedDRA 16.1 |
| ||
| Non-cardiac chest pain | General disorders | MedDRA 16.1 |
| ||
| Infusion site extravasation | General disorders | MedDRA 16.1 |
| ||
| Injection site vasculitis | General disorders | MedDRA 16.1 |
| ||
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.1 |
| ||
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 16.1 |
| ||
| Liver disorder | Hepatobiliary disorders | MedDRA 16.1 |
| ||
| Gallbladder polyp | Hepatobiliary disorders | MedDRA 16.1 |
| ||
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 16.1 |
| ||
| Drug hypersensitivity | Immune system disorders | MedDRA 16.1 |
| ||
| Hypersensitivity | Immune system disorders | MedDRA 16.1 |
| ||
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 16.1 |
| ||
| Sarcoidosis | Immune system disorders | MedDRA 16.1 |
| ||
| Bronchitis | Infections and infestations | MedDRA 16.1 |
| ||
| Cellulitis | Infections and infestations | MedDRA 16.1 |
| ||
| Chronic sinusitis | Infections and infestations | MedDRA 16.1 |
| ||
| Cystitis | Infections and infestations | MedDRA 16.1 |
| ||
| Cytomegalovirus infection | Infections and infestations | MedDRA 16.1 |
| ||
| Folliculitis | Infections and infestations | MedDRA 16.1 |
| ||
| Gastroenteritis | Infections and infestations | MedDRA 16.1 |
| ||
| Hepatitis viral | Infections and infestations | MedDRA 16.1 |
| ||
| Herpes simplex | Infections and infestations | MedDRA 16.1 |
| ||
| Herpes zoster | Infections and infestations | MedDRA 16.1 |
| ||
| Infection | Infections and infestations | MedDRA 16.1 |
| ||
| Laryngitis | Infections and infestations | MedDRA 16.1 |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 |
| ||
| Oral candidiasis | Infections and infestations | MedDRA 16.1 |
| ||
| Paronychia | Infections and infestations | MedDRA 16.1 |
| ||
| Pneumonia | Infections and infestations | MedDRA 16.1 |
| ||
| Rhinitis | Infections and infestations | MedDRA 16.1 |
| ||
| Sinusitis | Infections and infestations | MedDRA 16.1 |
| ||
| Skin infection | Infections and infestations | MedDRA 16.1 |
| ||
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 |
| ||
| Urinary tract infection | Infections and infestations | MedDRA 16.1 |
| ||
| Viral infection | Infections and infestations | MedDRA 16.1 |
| ||
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 16.1 |
| ||
| Bacterial infection | Infections and infestations | MedDRA 16.1 |
| ||
| Acarodermatitis | Infections and infestations | MedDRA 16.1 |
| ||
| Aspergillus infection | Infections and infestations | MedDRA 16.1 |
| ||
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 16.1 |
| ||
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 16.1 |
| ||
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 16.1 |
| ||
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 |
| ||
| Amylase increased | Investigations | MedDRA 16.1 |
| ||
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 |
| ||
| Beta 2 microglobulin increased | Investigations | MedDRA 16.1 |
| ||
| Blood albumin decreased | Investigations | MedDRA 16.1 |
| ||
| Blood bilirubin increased | Investigations | MedDRA 16.1 |
| ||
| Blood creatinine increased | Investigations | MedDRA 16.1 |
| ||
| Blood immunoglobulin A decreased | Investigations | MedDRA 16.1 |
| ||
| Blood immunoglobulin G decreased | Investigations | MedDRA 16.1 |
| ||
| Blood immunoglobulin M decreased | Investigations | MedDRA 16.1 |
| ||
| Blood lactate dehydrogenase increased | Investigations | MedDRA 16.1 |
| ||
| Blood potassium decreased | Investigations | MedDRA 16.1 |
| ||
| Blood urea increased | Investigations | MedDRA 16.1 |
| ||
| Blood uric acid increased | Investigations | MedDRA 16.1 |
| ||
| C-reactive protein increased | Investigations | MedDRA 16.1 |
| ||
| CD4 lymphocytes decreased | Investigations | MedDRA 16.1 |
| ||
| Electrocardiogram QT prolonged | Investigations | MedDRA 16.1 |
| ||
| Eosinophil count increased | Investigations | MedDRA 16.1 |
| ||
| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.1 |
| ||
| Blood urine present | Investigations | MedDRA 16.1 |
| ||
| Haemoglobin decreased | Investigations | MedDRA 16.1 |
| ||
| Low density lipoprotein increased | Investigations | MedDRA 16.1 |
| ||
| Lymphocyte count decreased | Investigations | MedDRA 16.1 |
| ||
| Lymphocyte count increased | Investigations | MedDRA 16.1 |
| ||
| Monocyte count decreased | Investigations | MedDRA 16.1 |
| ||
| Neutrophil count decreased | Investigations | MedDRA 16.1 |
| ||
| Neutrophil count increased | Investigations | MedDRA 16.1 |
| ||
| Platelet count decreased | Investigations | MedDRA 16.1 |
| ||
| Protein total decreased | Investigations | MedDRA 16.1 |
| ||
| Protein urine | Investigations | MedDRA 16.1 |
| ||
| Red blood cell count decreased | Investigations | MedDRA 16.1 |
| ||
| Weight decreased | Investigations | MedDRA 16.1 |
| ||
| Weight increased | Investigations | MedDRA 16.1 |
| ||
| White blood cell count decreased | Investigations | MedDRA 16.1 |
| ||
| White blood cell count increased | Investigations | MedDRA 16.1 |
| ||
| Blood bilirubin decreased | Investigations | MedDRA 16.1 |
| ||
| Neutrophil percentage decreased | Investigations | MedDRA 16.1 |
| ||
| Neutrophil percentage increased | Investigations | MedDRA 16.1 |
| ||
| Electrocardiogram ST-T segment abnormal | Investigations | MedDRA 16.1 |
| ||
| Blood alkaline phosphatase increased | Investigations | MedDRA 16.1 |
| ||
| Occult blood | Investigations | MedDRA 16.1 |
| ||
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 |
| ||
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 |
| ||
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 |
| ||
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 |
| ||
| Dizziness | Nervous system disorders | MedDRA 16.1 |
| ||
| Dizziness postural | Nervous system disorders | MedDRA 16.1 |
| ||
| Dysgeusia | Nervous system disorders | MedDRA 16.1 |
| ||
| Headache | Nervous system disorders | MedDRA 16.1 |
| ||
| Neuropathy peripheral | Nervous system disorders | MedDRA 16.1 |
| ||
| Paraesthesia | Nervous system disorders | MedDRA 16.1 |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 16.1 |
| ||
| Sensory disturbance | Nervous system disorders | MedDRA 16.1 |
| ||
| Tremor | Nervous system disorders | MedDRA 16.1 |
| ||
| Lacunar infarction | Nervous system disorders | MedDRA 16.1 |
| ||
| Insomnia | Psychiatric disorders | MedDRA 16.1 |
| ||
| Haematuria | Renal and urinary disorders | MedDRA 16.1 |
| ||
| Nephrolithiasis | Renal and urinary disorders | MedDRA 16.1 |
| ||
| Pollakiuria | Renal and urinary disorders | MedDRA 16.1 |
| ||
| Urinary retention | Renal and urinary disorders | MedDRA 16.1 |
| ||
| Breast swelling | Reproductive system and breast disorders | MedDRA 16.1 |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
| ||
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
| ||
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
| ||
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
| ||
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
| ||
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 |
| ||
| Acne | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Papule | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA 16.1 |
| ||
| Tooth extraction | Surgical and medical procedures | MedDRA 16.1 |
| ||
| Flushing | Vascular disorders | MedDRA 16.1 |
| ||
| Hypertension | Vascular disorders | MedDRA 16.1 |
| ||
| Hypotension | Vascular disorders | MedDRA 16.1 |
| ||
| Orthostatic hypotension | Vascular disorders | MedDRA 16.1 |
| ||
| Phlebitis | Vascular disorders | MedDRA 16.1 |
| ||
| Vascular pain | Vascular disorders | MedDRA 16.1 |
| ||
| Vasculitis | Vascular disorders | MedDRA 16.1 |
| ||
| Hot flush | Vascular disorders | MedDRA 16.1 |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Toshihiko Nagase | SymBio Pharmaceuticals | +81-3-5472-1125 |
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Male |
|
| 1 |
|
| 2 |
|
| Lymphoplasmacytic lymphoma |
|
| Splenic marginal zone lymphoma |
|
| B-EMZL(MALT lymphoma) |
|
| Nodal marginal zone B-cell lymphoma |
|
| Follicular lymphoma |
|
| Mantle cell lymphoma |
|
| III |
|
| IV |
|
| 1 region |
|
| 2 regions |
|
| 3 regions |
|
| 4 regions or more |
|
| 2 or more lesions |
|
| ˂5 cm |
|
| ˂7 cm |
|
| High |
|
| High |
|
| High |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| Negative |
|
| Undetermined |
|
| No |
|
| Unknown |
|
| No |
|
| No |
|
| Intermediate |
|
| High |
|
| Intermediate (Low) |
|
| Intermediate (High) |
|
| High |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Any adverse event |
| |||||
| Adverse drug reaction |
| |||||
| SAE |
| |||||
| Death |
| |||||
| Discontinuation due to adverse events |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Grade 3 : AST(GOT) |
| |||||
| Grade 3 : ALT(GPT) |
| |||||
| Grade 3 : γ-GTP |
| |||||
| Grade 4 : Uric acid |
| |||||
| Grade 3 : Na decrease |
| |||||
| Grade 3 : K decrease |
| |||||
| Grade 3 : K increase |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Grade 3 : White blood cell count decreased |
| |||||
| Grade 4 : White blood cell count decreased |
| |||||
| Grade 3 : Neutrophil count decreased |
| |||||
| Grade 4 : Neutrophil count decreased |
| |||||
| Grade 3 : Lymphocyte count decreased |
| |||||
| Grade 4 : Lymphocyte count decreased |
| |||||
| Grade 3 : Haemoglobin decreased |
| |||||
| Grade 3 : Platelet count decreased |
| |||||
| Grade 4 : Platelet count decreased |
|