Phase III Study of SyB L-0501 in Combination With Rituximab to Treat Recurrent/Relapsed Diffuse Large B-Cell Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2019-12-31

Brief Summary

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The purpose of this study is to determine the efficacy of SyB L-0501 in combination with rituximab in patients with recurrent/relapsed diffuse large B-cell lymphoma.

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Detailed Description

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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 Day 2 and Day 3 in combination with rituximab at 375 mg/m\^2 on Day 1 of each 21-day cycle in patients with recurrent/relapsed diffuse large B-cell lymphoma.

Conditions

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Assess the Efficacy and Safety of SyB L-0501 in Combination With Rituximab in Patients With Recurrent or Relapsed DLBCL

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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).
2. Patients with documented Cluster of differentiation 20 (CD20)-positive for lymphoma cells.
3. Patient with recurrent or relapsed DLBCL after R-CHOP-like theraphy as the firstline therapy.
4. Patients with measurable lesions \>1.5 cm in major axes.
5. Patients who are expected to survive for at least 3 months.
6. Patients aged 20 or above at the time informed consent is obtained.
7. Patient with Performance Status (P.S.) 0-1.
8. Patients with adequately maintained organ function.

Exclusion Criteria

1. Patients who have been without treatment for less than 3 weeks after prior treatment.
2. Patients who can be candidates for autologous peripheral blood stem cell transplantation at the discretion of the investigator.
3. Patients who received adequate prior treatments and did not respond to any of them.
4. Patient who received prior chemotherapy 3 regimens or more.
5. Patients with central nervous system (CNS) involvement or patients with clinical symptoms suggestive of CNS involvement.
6. Patient with serious active infection.
7. Patient with serious complication.
8. Patient with complication or medical history of serious cardiac disease.
9. Patient with serious gastrointestinal symptoms.
10. Patient with malignant pleural effusion, pericardial effusion, or ascites retention.
11. Patients positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or HIV antibody.
12. Patient with serious bleeding tendency.
13. Patient with a fever of 38.0°C or higher.
14. Patients with, or confirmed in the past to have had, interstitial pneumonia, pulmonary fibrosis, or pulmonary emphysema.
15. 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.
16. Patients with, or confirmed in the past to have had, autoimmune hemolytic anemia.
17. Patient who received bendamustin hydrochloride in the past.
18. 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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No