Status:
COMPLETED
Phase III Study of SyB L-0501 in Combination With Rituximab to Treat Recurrent/Relapsed Diffuse Large B-Cell Lymphoma
Lead Sponsor:
SymBio Pharmaceuticals
Conditions:
Assess the Efficacy and Safety of SyB L-0501 in Combination With Rituximab in Patients With Recurrent or Relapsed DLBCL
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03372837
Start Date
January 15 2018
End Date
December 31 2019
Last Update
April 18 2023
Active Locations (29)
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1
Research Site
Nagoya, Aichi-ken, Japan
2
Research Site
Toyoake, Aichi-ken, Japan
3
Research Site
Matsuyama, Ehime, Japan
4
Research Site
Maebashi, Gunma, Japan