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)
1 other identifier
interventional
56
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2007
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 28, 2008
CompletedFirst Posted
Study publicly available on registry
February 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedJuly 22, 2010
May 1, 2010
1.8 years
January 28, 2008
July 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response rate based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]
[Treatment period]
Secondary Outcomes (1)
CR rate of overall results based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]
[Treatment Period]
Interventions
bendamustine hydrochloride is administered by 60-min drip infusion at 120 mg/m2/day for 2 consecutive days, and the course is then observed for 19 days. This is one cycle and administration is repeated for 3 - 6 cycles. From the second cycle, the dose is reduced or administration is discontinued as required based on adverse events observed in the previous cycle or observation of the course.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Nagoya, Aichi-ken, Japan
Unknown Facility
Kashiwa, Chiba, Japan
Unknown Facility
Fukuoka, Fukuoka, Japan
Unknown Facility
Sapporo, Hokkaido, Japan
Unknown Facility
Kagoshima, Kagoshima-ken, Japan
Unknown Facility
Isehara, Kanagawa, Japan
Unknown Facility
Kumamoto, Kumamoto, Japan
Unknown Facility
Kyoto, Kyoto, Japan
Unknown Facility
Sendai, Miyagi, Japan
Unknown Facility
Nagoya, Nagoya, Japan
Unknown Facility
Moriguchi, Osaka, Japan
Unknown Facility
Hamamatsu, Shizuoka, Japan
Unknown Facility
Utsunomiya, Tochigi, Japan
Unknown Facility
Chūō, Tokyo, Japan
Unknown Facility
Koto, Tokyo, Japan
Unknown Facility
Shibuya City, Tokyo, Japan
Unknown Facility
Shinagawa, Tokyo, Japan
Related Publications (1)
Ohmachi 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: 20626754DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kensei Tobinai, MD, PhD
National Cancer Center Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 28, 2008
First Posted
February 11, 2008
Study Start
December 1, 2007
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
July 22, 2010
Record last verified: 2010-05