Phase 2
Completed N=59
Study of SyB L-0501 in Combination With Rituximab to Treat Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Source: ClinicalTrials.gov NCT01118845 ↗Enrolled (actual)
59
Serious AEs
23.7%
Results posted
Jul 2013
Primary outcomePrimary: The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma — 62.7 Percentage of Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma |
62.7 | — |
| SECONDARY The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma |
37.3 | — |
| SECONDARY Progression Free Survival (PFS) |
200.0 | — |
| SECONDARY Number of Subjects With Adverse Event |
59; 14 | — |
| SECONDARY Number of Adverse Events |
1848; 23 | — |
| SECONDARY Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values |
2; 54 | — |
| SECONDARY Number of Subjects With Grade ≥3 Physical Examination Finding |
1; 22 | — |
| SECONDARY Concomitant Medication Usage |
58; 50; 59; 59 | — |
| SECONDARY The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan |
8365.82 | — |
| SECONDARY The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan |
1.0 | — |
| SECONDARY The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan |
10394.39 | — |
| SECONDARY The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan |
0.39 | — |
| SECONDARY The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea |
8095.99 | — |
| SECONDARY The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea |
0.9 | — |
| SECONDARY The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea |
9218.56 | — |
| SECONDARY The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea |
0.48 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01118845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.