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

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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

NCT03372837•SymBio Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

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.
+8 more criteria

Locations (29)

Research Site

Nagoya, Aichi-ken, Japan

Research Site

Toyoake, Aichi-ken, Japan

Research Site

Matsuyama, Ehime, Japan

Research Site

Maebashi, Gunma, Japan

Research Site

Ōta, Gunma, Japan

Research Site

Shibukawa, Gunma, Japan

Research Site

Fukuyama, Hiroshima, Japan

Research Site

Sapporo, Hokkaido, Japan

Research Site

Kobe, Hyōgo, Japan

Research Site

Isehara, Kanagawa, Japan

Key Dates

Start Date

January 15, 2018

Primary Completion Date

December 31, 2019

Completion Date

December 31, 2019

Last Updated

April 18, 2023

Enrollment

ACTUAL participants

Conditions

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

Interventions

Rituximab

DRUG