Clinical trial · Interventional
A Phase I Study of Bendamustine Hydrochloride in Patients With Indolent B-cell Non-Hodgkin's Lymphoma
A Multicenter, Open Study to Assess the Tolerability, Pharmacokinetics and Antitumor Effect of Bendamustine Hydrochloride (SyB L-0501: 90 or 120 mg/m2/Day) Administered Intravenously for Two Days in Patients With Indolent Lymphoma
NCT00389051CI-TRIAL-00047860completedPhase 1ClinicalTrials.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 tolerability, pharmacokinetics and antitumor effect of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell Non-Hodgkin's Lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 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
- Non-Hematological toxicity; > grade three(CTCAE v.3.0), during the treatment cycle (twenty one days)
Secondary outcomes (2)
- measure
- All adverse events or adverse reactions, during the treatment cycle (twenty one days)
- measure
- Pharmacokinetics profile
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Indolent B cell 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. * Patients who had not received treatment (chemotherapy, antibody therapy and radiation/ radiotherapy) for more than 4 weeks following prior therapy and who are judged to carry no effect from the prior therapy. * Patients aged from 20 to less than 75 years. * Patients who had agreed in-patient during first course therapy. * 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 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)
- DERIVEDOgura M, Uchida T, Taniwaki M, Ando K, Watanabe T, Kasai M, Matsumoto Y, Shimizu D, Ogawa Y, Ohmachi K, Yokoyama H, Tobinai K; Japanese Bendamustine Lymphoma Study Group. Phase I and pharmacokinetic study of bendamustine hydrochloride in relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma. Cancer Sci. 2010 Sep;101(9):2054-8. doi: 10.1111/j.1349-7006.2010.01633.x. PMID 20594195