- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03372837
Phase III Study of SyB L-0501 in Combination With Rituximab to Treat Recurrent/Relapsed Diffuse Large B-Cell Lymphoma
A Multicenter, Open-label Phase III Study of SyB L-0501 in Combination With Rituximab in Patients With Recurrent or Relapsed Diffuse Large B-Cell Lymphoma
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Akita, Japan
- Research Site
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Fukuoka, Japan
- Research Site
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Fukushima, Japan
- Research Site
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Ibaraki, Japan
- Research Site
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Kumamoto, Japan
- Research Site
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Kyoto, Japan
- Research Site
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Nagasaki, Japan
- Research Site
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Okayama, Japan
- Research Site
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Osaka, Japan
- Research Site
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Yamagata, Japan
- Research Site
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Aichi
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Nagoya, Aichi, Japan
- Research Site
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Toyoake, Aichi, Japan
- Research Site
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Ehime
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Matsuyama, Ehime, Japan
- Research Site
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Gunma
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Maebashi, Gunma, Japan
- Research Site
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Shibukawa, Gunma, Japan
- Research Site
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Ōta, Gunma, Japan
- Research Site
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Hiroshima
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Fukuyama, Hiroshima, Japan
- Research Site
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Hokkaido
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Sapporo, Hokkaido, Japan
- Research Site
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Hyogo
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Kobe, Hyogo, Japan
- Research Site
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Kanagawa
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Isehara, Kanagawa, Japan
- Research Site
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Miyagi
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Sendai, Miyagi, Japan
- Research Site
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Osaka
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Osakasayama, Osaka, Japan
- Research Site
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Shimane
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Izumo, Shimane, Japan
- Research Site
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Tochigi
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Mibu, Tochigi, Japan
- Research Site
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Shimotsuke, Tochigi, Japan
- Research Site
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Tokyo
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Chuo-ku, Tokyo, Japan
- Research Site
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Koto-ku, Tokyo, Japan
- Research Site
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Shibuya-ku, Tokyo, Japan
- Research Site
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Shinagawa-ku, Tokyo, Japan
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria Patients who satisfy all of the conditions listed below.
- Patients with histopathologically confirmed diffuse large B-cell lymphoma (DLBCL) except for transformed lymphoma on the basis of World Health Organization (WHO) histological classification (4th ed., 2008).
- Patients with documented Cluster of differentiation 20 (CD20)-positive for lymphoma cells.
- Patient with recurrent or relapsed DLBCL after R-CHOP-like theraphy as the firstline therapy.
- Patients with measurable lesions >1.5 cm in major axes.
- Patients who are expected to survive for at least 3 months.
- Patients aged 20 or above at the time informed consent is obtained.
- Patient with Performance Status (P.S.) 0-1.
- Patients with adequately maintained organ function.
Exclusion Criteria The study subject should be excluded if any one of the following condition exists.
- Patients who have been without treatment for less than 3 weeks after prior treatment.
- Patients who can be candidates for autologous peripheral blood stem cell transplantation at the discretion of the investigator.
- Patients who received adequate prior treatments and did not respond to any of them.
- Patient who received prior chemotherapy 3 regimens or more.
- Patients with central nervous system (CNS) involvement or patients with clinical symptoms suggestive of CNS involvement.
- Patient with serious active infection.
- Patient with serious complication.
- Patient with complication or medical history of serious cardiac disease.
- Patient with serious gastrointestinal symptoms.
- Patient with malignant pleural effusion, pericardial effusion, or ascites retention.
- Patients positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or HIV antibody.
- Patient with serious bleeding tendency.
- Patient with a fever of 38.0°C or higher.
- Patients with, or confirmed in the past to have had, interstitial pneumonia, pulmonary fibrosis, or pulmonary emphysema.
- Patients with active multiple primary cancer or patients with a history of other malignant cancer within the past 5 years, except for basal cell cancer of the skin, squamous cell cancer, or cervical cancer in situ.
- Patients with, or confirmed in the past to have had, autoimmune hemolytic anemia.
- Patient who received bendamustin hydrochloride in the past.
- Patients who received cytokine preparation such as erythropoietin or granulocyte colony-stimulating factor (G-CSF) or blood transfusions within 2 weeks before the examination at registration for this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SyB L-0501
The administration of SyB L-0501 at 120 mg/m^2/day by intravenous infusion on Day 2 and Day 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate
Time Frame: up to 30 weeks
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Complete Response (CR) + Partial Response (PR) Determined on the Basis of Revised Response Criteria for Malignant Lymphoma (Revised RC 2007)
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up to 30 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Response (CR) Rate
Time Frame: up to 30 weeks
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Determined on the Basis of Revised Response Criteria for Malignant Lymphoma (Revised RC 2007)
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up to 30 weeks
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Progression Free Survival (PFS)
Time Frame: up to 30 weeks
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PFS = day of the first PFS event - day of start of study treatment + 1
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up to 30 weeks
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Duration of Response (DOR)
Time Frame: up to 30 weeks
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DOR is the period from the date of achieving CR, 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% Confidence Interval (CI ) were calculated using Greenwood's formula.
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up to 30 weeks
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Overall Survival (OS)
Time Frame: up to 30 weeks.
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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.
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up to 30 weeks.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Disease Attributes
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Recurrence
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- 2017002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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