Clinical trial · Interventional
Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma
Phase II Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma (Multicenter, Open-label Study)
NCT00612183CI-TRIAL-00003694completedPhase 2ClinicalTrials.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 assess the antitumor effects and safety of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell non-Hodgkin's lymphoma or mantle cell lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bendamustine hydrochloride | Drug | Bendamustine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall response rate based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]
- timeFrame
- [Treatment period]
Secondary outcomes (1)
- measure
- CR rate of overall results based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]
- timeFrame
- [Treatment Period]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Non-Hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. No restrictions regarding gender. * Patients with histologically or cytologically confirmed indolent B cell Non-Hodgkin's lymphoma or mantle cell lymphoma. * Patients who had not received treatment for at least 4 weeks (for at least 12 weeks in the case of antibody therapy) after completion of prior therapy and who are judged to carry no effect from the prior therapy. * Patients aged from 20 to less than 75 years. * Performance Status (P.S.): 0 or 1. * Patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions). * Patients from whom written consent to participate in this study has been obtained. Exclusion Criteria: Patients who meet any of the following criteria will be excluded. * Patients with apparent infections. * Patients with serious complications (hepatic failure or renal failure). * Patients with complication or history of serious heart failure (e.g. cardiac infarction, ischemic heart disease). * Patients with serious digestive symptoms (nausea/ vomiting/ diarrhea). * Patients who are known to be positive for HBV, HCV or HIC. * Patients receiving other investigational drugs within 3 months before registration in the study. * Patients with allogenic bone-marrow transplant. * Women who are pregnant, of childbearing potential, or lactating. * Patients who do not agree to contraception. * Otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.
References
Publications (1)
- DERIVEDOhmachi K, Ando K, Ogura M, Uchida T, Itoh K, Kubota N, Ishizawa K, Yamamoto J, Watanabe T, Uike N, Choi I, Terui Y, Usuki K, Nagai H, Uoshima N, Tobinai K; Japanese Bendamustine Lymphoma Study Group. Multicenter phase II study of bendamustine for relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma. Cancer Sci. 2010 Sep;101(9):2059-64. doi: 10.1111/j.1349-7006.2010.01635.x. PMID 20626754