Clinical trial · Interventional
Study of SyB L-0501 in Combination With Rituximab to Treat Relapsed/Refractory Diffuse Large B-Cell Lymphoma
A Multinational, Multicenter, Open-Label Phase II Study of SyB L-0501 in Combination With Rituximab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
NCT01118845CI-TRIAL-00011224completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the efficacy of SyB L-0501 in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse, Mantle Cell Lymphoma, Lymphoma | Gastric Diffuse Adenocarcinoma | ALIAS | 0.85 |
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Large B-Cell, Diffuse | — | UNRESOLVED | — |
| Lymphoma, Large Cell | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
| SyB L-0501 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SyB L-0501
- interventionNames
- Drug: SyB L-0501
- Drug: Rituximab
Primary outcomes (1)
- measure
- The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma
- timeFrame
- up to 30 weeks
- description
- CR: Disappearance of all evidence of disease. PR: Regression of measurable disease and no new sites. For the criteria for CR, See Outcome measure 2 description. The criteria for PR is as below. Nodal Masses: more than 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes 1. FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site 2. Variably FDG-avid or PET negative; regression on CT Spleen, Liver: more than 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified
Secondary outcomes (15)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with documented Cluster of differentiation 20 (CD20)-positive for lymphoma cells * Patients with measurable lesions * Patients with measurable lesions \>1.5 cm in major axes * Relapsed or refractory after 1 to 3 prior therapeutic treatments for diffuse large B-cell lymphoma. * Patients who are expected to survive for at least 3 months * Patients aged from 20 to 75 years at the time informed consent is obtained * Performance Status (P.S.) of 0 to 1 at initial administration of the study drug * Patients with adequately maintained organ functions * Patients capable of personally giving voluntary informed consent in writing to participate in the study Exclusion Criteria: * 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. * Patients with central nervous system (CNS) involvement or patients with clinical symptoms suggestive of CNS involvement. * Patients with serious, active infections * Patients with serious complications * Patients with complications or medical history of serious cardiac disease * Patients with serious gastrointestinal symptoms * Patients with malignant pleural effusion, cardiac effusion, or ascites retention * Patients positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or HIV antibody * Patients with serious bleeding tendencies * Patients 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 * Patients who received SyB L-0501 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 * Patients who received other investigational products or unapproved medication within 3 months before registration in this study
References
Publications (0)
Data not yet available
No reference posted for this study.