search
Back to results

Efficacy and Safety Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B Cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma

Primary Purpose

Low-grade B Cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma Where Hematopoietic Stem Cell Transplantation is Not Indicated

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
SyB L-0501
rituximab
Sponsored by
SymBio Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low-grade B Cell Non-Hodgkin's Lymphoma

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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):

    • Small lymphocytic lymphoma
    • Splenic marginal zone B-cell lymphoma
    • Lymphoplasmacytic lymphoma
    • Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma)
    • Nodal marginal zone B-cell lymphoma
    • Follicular lymphoma (Grade 1, 2, 3a)
    • Mantle cell lymphoma
  2. Patients with a measurable lesion ( > 1.5 cm in major axis on CT)
  3. Patients without a medical history

  4. 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

      1. Fever exceeding 38.0ºC of unknown cause
      2. Night sweats
      3. Weight decrease exceeding 10% within 6 months before patient registration
    • 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
  5. Patients expected to live for at least 3 months
  6. Patients aged between 20 and 79 years (at the time of registration)
  7. Patients whose Eastern Cooperative Oncology Group (ECOG) performance status (P.S.) is 0～2

  8. Patients with adequately maintained major organ function (bone marrow, heart, lungs, liver, kidneys)

    • Neutrophil count: not less than 1,500 /mm3
    • Platelet count: not less than 75,000 /mm3
    • Aspartate aminotransferase (AST)[Glutamic oxaloacetic transaminase (GOT)]: not more than 3 times the standard upper limit for the site
    • Alanine aminotransferase (ALT)[Glutamic pyruvic transaminase (GPT)]: not more than 3 times the standard upper limit for the site
    • Total bilirubin: not more than 1.5 times the standard upper limit for the site
    • Serum creatinine: not more than 1.5 times the standard upper limit for the site
    • Arterial partial pressure of oxygen (PaO2): not less than 65 mmHg
    • Electrocardiogram shows no abnormal findings that require treatment
    • Echocardiogram of left ventricular ejection fraction (LVEF): not less than 55%
  9. 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

  1. Patients whose transformation has been confirmed histopathologically
  2. Mantle cell lymphoma patients aged 65 years or younger
  3. Patients who were administered or received transfusion of cytokine formulations such as G-CSF (granulocyte colony stimulating factor) and erythropoietin within 14 days before pre-registration test
  4. Patients with severe active infectious disorders (receiving antibiotics, antifungals, or antivirus IV injection)
  5. Patients with serious complications (such as hepatic or renal failure)
  6. Patients with severe complications of cardiac disease (examples: myocardial infarction, ischemic heart disease) or its previous history within 2 years before patient registration, and patients with arrhythmia requiring a treatment
  7. Patients with serious gastrointestinal conditions (persistent or severe nausea/vomiting or diarrhea)
  8. Patients who are positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody or HIV antibody [if HBs or hepatitis B core (HBc) positive, patients whose hepatitis B virus (HBV)-DNA test results indicate positive]
  9. Patients with serious bleeding tendencies [such as disseminated intravascular coagulation (DIC)]
  10. Patients having or suspected of having symptoms indicative of the central nervous system (CNS) involvement
  11. Patients with interstitial pneumonitis, pulmonary fibrosis, pulmonary emphysema complications requiring treatment or its medical history.
  12. Patients with active multiple primary cancer
  13. Patients who received chemotherapy, radiotherapy, antibody therapy and antitumor steroid therapy in the past
  14. Patients with complications or medical history of autoimmune haemolytic anaemia
  15. Patients who were administered investigative or unapproved drugs within 3 months before patient registration
  16. Patients with addiction to drugs or narcotics, or alcoholism
  17. Patients who have previously received hematopoietic stem cell transplantation
  18. Patients who are or may be pregnant, lactating patients
  19. Patients, whether male or female, who do not agree to use contraception
  20. Patients otherwise judged by the investigator or the sub-investigator to be unsuitable for inclusion in the study

Sites / Locations

  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SyB L-0501＋rituximab

Arm Description

Outcomes

Primary Outcome Measures

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 Disappearance of all detectable disease LN* > 1.5 cm must decrease to ≤ 1.5 cm CRu: Fulfills all of the following LN >1.5 cm; SPD** decrease >75% indeterminate bone marrow LN: lymph nodes or nodal masses ** SPD: sum of the products of the greatest diameters

Secondary Outcome Measures

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%
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: [18F]fluorodeoxyglucose (FDG)-avid or PET positive prior to therapy; mass of any size permitted if PET negative. Variably FDG-avid or PET negative; regression to normal size on CT. Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative.
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 FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site Variably FDG-avid or PET negative; regression on CT 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.
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.
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.
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).
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.
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.
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.
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
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

Full Information

First Posted
October 29, 2012
Last Updated
March 24, 2016
Sponsor
SymBio Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT01718691
Brief Title
Efficacy and Safety Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B Cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma
Official Title
Phase II Clinical Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B-cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma (Multicenter, Open-label).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SymBio Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low-grade B Cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma Where Hematopoietic Stem Cell Transplantation is Not Indicated

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SyB L-0501＋rituximab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SyB L-0501
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
rituximab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)
Description
The criteria for CR and CRu based on IWRC are shown below. CR: Fulfills all of the following Disappearance of all detectable disease LN* > 1.5 cm must decrease to ≤ 1.5 cm CRu: Fulfills all of the following LN >1.5 cm; SPD** decrease >75% indeterminate bone marrow LN: lymph nodes or nodal masses ** SPD: sum of the products of the greatest diameters
Time Frame
Up to 30 weeks
Secondary Outcome Measure Information:
Title
Overall Response Rate (Antitumor Effect: PR or Better) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)
Description
The criteria for PR based on IWRC are shown below. PR: SPD regressed > 50%
Time Frame
Up to 30 weeks
Title
Complete Response Rate (CR) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)
Description
The criteria for CR based on the Revised RC are shown below. Definition: Disappearance of all evidence of disease Nodal Masses: [18F]fluorodeoxyglucose (FDG)-avid or PET positive prior to therapy; mass of any size permitted if PET negative. Variably FDG-avid or PET negative; regression to normal size on 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
Title
Overall Response Rate (PR or Better) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)
Description
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 FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site Variably FDG-avid or PET negative; regression on CT 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.
Time Frame
Up to 30 weeks
Title
Complete Response Rate Based on WHO Handbook for Reporting Results of Cancer Treatment (1979)
Description
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.
Time Frame
Up to 30 weeks
Title
Overall Response Rate (PR or Better) Based on "WHO Handbook for Reporting Results of Cancer Treatment (1979)"
Description
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.
Time Frame
Up to 30 weeks
Title
Progression-Free Survival (PFS)
Description
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).
Time Frame
Up to 30 weeks
Title
Duration of Response (DOR)
Description
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.
Time Frame
Up to 30 weeks
Title
Overall Survival (OS)
Description
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.
Time Frame
Up to 30 weeks
Title
Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event
Description
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.
Time Frame
up to 30 weeks
Title
Laboratory Test Abnormalities (Biochemical Tests)
Description
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
Time Frame
up to 30 weeks
Title
Laboratory Test Abnormalities (Hematology Tests)
Description
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
Time Frame
up to 30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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): Small lymphocytic lymphoma Splenic marginal zone B-cell lymphoma Lymphoplasmacytic lymphoma Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) Nodal marginal zone B-cell lymphoma Follicular lymphoma (Grade 1, 2, 3a) Mantle cell lymphoma 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 Fever exceeding 38.0ºC of unknown cause Night sweats Weight decrease exceeding 10% within 6 months before patient registration 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) Neutrophil count: not less than 1,500 /mm3 Platelet count: not less than 75,000 /mm3 Aspartate aminotransferase (AST)[Glutamic oxaloacetic transaminase (GOT)]: not more than 3 times the standard upper limit for the site Alanine aminotransferase (ALT)[Glutamic pyruvic transaminase (GPT)]: not more than 3 times the standard upper limit for the site Total bilirubin: not more than 1.5 times the standard upper limit for the site Serum creatinine: not more than 1.5 times the standard upper limit for the site Arterial partial pressure of oxygen (PaO2): not less than 65 mmHg Electrocardiogram shows no abnormal findings that require treatment Echocardiogram of left ventricular ejection fraction (LVEF): not less than 55% 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 Patients whose transformation has been confirmed histopathologically Mantle cell lymphoma patients aged 65 years or younger Patients who were administered or received transfusion of cytokine formulations such as G-CSF (granulocyte colony stimulating factor) and erythropoietin within 14 days before pre-registration test Patients with severe active infectious disorders (receiving antibiotics, antifungals, or antivirus IV injection) Patients with serious complications (such as hepatic or renal failure) Patients with severe complications of cardiac disease (examples: myocardial infarction, ischemic heart disease) or its previous history within 2 years before patient registration, and patients with arrhythmia requiring a treatment Patients with serious gastrointestinal conditions (persistent or severe nausea/vomiting or diarrhea) Patients who are positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody or HIV antibody [if HBs or hepatitis B core (HBc) positive, patients whose hepatitis B virus (HBV)-DNA test results indicate positive] Patients with serious bleeding tendencies [such as disseminated intravascular coagulation (DIC)] Patients having or suspected of having symptoms indicative of the central nervous system (CNS) involvement Patients with interstitial pneumonitis, pulmonary fibrosis, pulmonary emphysema complications requiring treatment or its medical history. Patients with active multiple primary cancer Patients who received chemotherapy, radiotherapy, antibody therapy and antitumor steroid therapy in the past Patients with complications or medical history of autoimmune haemolytic anaemia Patients who were administered investigative or unapproved drugs within 3 months before patient registration Patients with addiction to drugs or narcotics, or alcoholism Patients who have previously received hematopoietic stem cell transplantation Patients who are or may be pregnant, lactating patients Patients, whether male or female, who do not agree to use contraception Patients otherwise judged by the investigator or the sub-investigator to be unsuitable for inclusion in the study
Facility Information:
Facility Name
Research site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Research site
City
Kashiwa
State/Province
Chiba
Country
Japan
Facility Name
Research site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Research site
City
Isehara
State/Province
Kanagawa
Country
Japan
Facility Name
Research site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Research site
City
Moriguchi
State/Province
Osaka
Country
Japan
Facility Name
Research site
City
Izumo
State/Province
Shimane
Country
Japan
Facility Name
Research site
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
Facility Name
Research site
City
Utsunomiya
State/Province
Tochigi
Country
Japan
Facility Name
Research site
City
Fukuoka
Country
Japan
Facility Name
Research site
City
Kagoshima
Country
Japan
Facility Name
Research site
City
Kyoto
Country
Japan
Facility Name
Research site
City
Nagasaki
Country
Japan
Facility Name
Research site
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B Cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma

We'll reach out to this number within 24 hrs