Status:
COMPLETED
A Phase I Study of Bendamustine Hydrochloride in Patients With Indolent B-cell Non-Hodgkin's Lymphoma
Lead Sponsor:
SymBio Pharmaceuticals
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
Brief Summary
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.
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
- 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
- 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.
Key Trial Info
Start Date :
October 31 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2007
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00389051
Start Date
October 31 2006
End Date
October 26 2007
Last Update
October 22 2020
Active Locations (4)
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1
Kanagawa, Japan
2
Kyoto, Japan
3
Nagoya, Japan
4
Tokyo, Japan