Phase III Study of SyB L-0501 in Combination With Rituximab to Treat Recurrent/Relapsed Diffuse Large B-Cell Lymphoma
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ClinicalTrials.gov Identifier: NCT03372837 |
Recruitment Status :
Completed
First Posted : December 14, 2017
Last Update Posted : April 18, 2023
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Condition or disease | Intervention/treatment | Phase |
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Assess the Efficacy and Safety of SyB L-0501 in Combination With Rituximab in Patients With Recurrent or Relapsed DLBCL | Drug: Rituximab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | January 15, 2018 |
Actual Primary Completion Date : | December 31, 2019 |
Actual Study Completion Date : | December 31, 2019 |
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. |
Drug: Rituximab
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. |
- Overall Response Rate [ Time Frame: up to 30 weeks ]Complete Response (CR) + Partial Response (PR) Determined on the Basis of Revised Response Criteria for Malignant Lymphoma (Revised RC 2007)
- Complete Response (CR) Rate [ Time Frame: up to 30 weeks ]Determined on the Basis of Revised Response Criteria for Malignant Lymphoma (Revised RC 2007)
- Progression Free Survival (PFS) [ Time Frame: up to 30 weeks ]PFS = day of the first PFS event - day of start of study treatment + 1
- Duration of Response (DOR) [ Time Frame: up to 30 weeks ]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.
- Overall Survival (OS) [ Time Frame: up to 30 weeks. ]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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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372837
Japan | |
Research Site | |
Nagoya, Aichi, Japan | |
Research Site | |
Toyoake, Aichi, Japan | |
Research Site | |
Matsuyama, Ehime, Japan | |
Research Site | |
Maebashi, Gunma, Japan | |
Research Site | |
Shibukawa, Gunma, Japan | |
Research Site | |
Ōta, Gunma, Japan | |
Research Site | |
Fukuyama, Hiroshima, Japan | |
Research Site | |
Sapporo, Hokkaido, Japan | |
Research Site | |
Kobe, Hyogo, Japan | |
Research Site | |
Isehara, Kanagawa, Japan | |
Research Site | |
Sendai, Miyagi, Japan | |
Research Site | |
Osakasayama, Osaka, Japan | |
Research Site | |
Izumo, Shimane, Japan | |
Research Site | |
Mibu, Tochigi, Japan | |
Research Site | |
Shimotsuke, Tochigi, Japan | |
Research Site | |
Chuo-ku, Tokyo, Japan | |
Research Site | |
Koto-ku, Tokyo, Japan | |
Research Site | |
Shibuya-ku, Tokyo, Japan | |
Research Site | |
Shinagawa-ku, Tokyo, Japan | |
Research Site | |
Akita, Japan | |
Research Site | |
Fukuoka, Japan | |
Research Site | |
Fukushima, Japan | |
Research Site | |
Ibaraki, Japan | |
Research Site | |
Kumamoto, Japan | |
Research Site | |
Kyoto, Japan | |
Research Site | |
Nagasaki, Japan | |
Research Site | |
Okayama, Japan | |
Research Site | |
Osaka, Japan | |
Research Site | |
Yamagata, Japan |
Responsible Party: | SymBio Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03372837 |
Other Study ID Numbers: |
2017002 |
First Posted: | December 14, 2017 Key Record Dates |
Last Update Posted: | April 18, 2023 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Diffuse large B-cell lymphoma, rituximab, SyB L-0501, combination therapy |
Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Recurrence Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Disease Attributes Pathologic Processes Lymphoma, Non-Hodgkin Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |