Status:
COMPLETED
A Phase I Clinical Trial of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma
Lead Sponsor:
SymBio Pharmaceuticals
Conditions:
Non-Hodgkin's Lymphoma
Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety of SyB L-0501 in combination with Rituximab to patients with aggressive B-cell non-Hodgkin's lymphoma, and to explore the recommended dose for the Pha...
Eligibility Criteria
Inclusion
- Aggressive B-cell non-Hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. No restrictions regarding gender.
- Patients with the following histologically confirmed CD20(+) B-cell non-Hodgkin's lymphoma:
- Diffuse large B-cell lymphoma
- Mantle cell lymphoma
- Transformed lymphoma
- Follicular lymphoma (Grade 3)
- Fail to CR in prior chemotherapy, or relapse following CR or recurrence following PR.
- Patients who are judged to carry no effect from the prior therapy (cancer chemotherapy, antibody therapy and radiation/ radiotherapy.
- Patients aged from 20 to 75 years at the time informed consent is obtained
- Patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions)
- Patients who can be hospitalized during the first cycle
- Patients capable of personally giving voluntary informed consent in writing to participate in the study
Exclusion
- Patients who meet any of the following criteria will be excluded.
- Patients with serious complications (hepatic or renal failure)
- Patients with complications or medical history of serious cardiac disease (e.g., myocardial infarction, ischemic heart disease)
- Patients with serious gastrointestinal symptoms (e.g., severe nausea, vomiting, or diarrhea)
- Patients positive for HBs antigen, HCV antibody, or HIV antibody
- Patients who received other investigational drug or unapproved medication within 3 months before registration in this study
- Patients who had history of hematopoietic stem cell transplantation or radioimmunotherapy
- Patients who are pregnant, of childbearing potential, or lactating
- Patients, whether male or female, who do not agree to contraception
- Patients otherwise judged by investigator or sub investigator to be unsuitable
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00794638
Start Date
November 1 2008
End Date
May 1 2010
Last Update
July 2 2021
Active Locations (4)
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1
Nagoya, Aichi-ken, Japan
2
Isehara, Kanagawa, Japan
3
Kyoto, Kyoto, Japan
4
Chuo-ku, Tokyo, Japan