Status:
COMPLETED
Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma
Lead Sponsor:
SymBio Pharmaceuticals
Conditions:
Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
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, vincri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00612183
Start Date
December 1 2007
End Date
September 1 2009
Last Update
July 22 2010
Active Locations (17)
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1
Nagoya, Aichi-ken, Japan
2
Kashiwa, Chiba, Japan
3
Fukuoka, Fukuoka, Japan
4
Sapporo, Hokkaido, Japan