Back to resultsClinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma
Primary Purpose
Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
bendamustine hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring non-Hodgkin's lymphoma, mantle cell lymphoma
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Overall response rate based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]
Secondary Outcome Measures
CR rate of overall results based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00612183
Brief Title
Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
SymBio Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Indolent B-cell Non-hodgkin's lymphoma is treated mainly with radiation and chemotherapy using a combination of chemotherapies, such as purine-analogues and CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone). After the approval of an antibody therapy agent Rituximab®, it alone or combination with CHOP has been introduced. Bendamustine hydrochloride has a unique structure compared with the marketed agents, and has an innovative mechanism of action. Thus, it is expected that Bendamustine hydrochloride will provide new alternatives for patients with refractory/recurrent indolent B-cell Non-hodgkin's lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma
Keywords
non-Hodgkin's lymphoma, mantle cell lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
bendamustine hydrochloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall response rate based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]
Time Frame
[Treatment period]
Secondary Outcome Measure Information:
Title
CR rate of overall results based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]
Time Frame
[Treatment Period]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kensei Tobinai, MD, PhD
Organizational Affiliation
National Cancer Center Hospital
Official's Role
Study Chair
Facility Information:
City
Nagoya
State/Province
Aichi
Country
Japan
City
Kashiwa
State/Province
Chiba
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Isehara
State/Province
Kanagawa
Country
Japan
City
Sendai
State/Province
Miyagi
Country
Japan
City
Moriguchi
State/Province
Osaka
Country
Japan
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
City
Utsunomiya
State/Province
Tochigi
Country
Japan
City
Chuo
State/Province
Tokyo
Country
Japan
City
Koto
State/Province
Tokyo
Country
Japan
City
Shibuya
State/Province
Tokyo
Country
Japan
City
Shinagawa
State/Province
Tokyo
Country
Japan
City
Fukuoka
Country
Japan
City
Kagoshima
Country
Japan
City
Kumamoto
Country
Japan
City
Kyoto
Country
Japan
City
Nagoya
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
20626754
Citation
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.
Results Reference
derived
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Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma
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