- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00794638
A Phase I Clinical Trial of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma
July 1, 2021 updated by: SymBio Pharmaceuticals
A Multicenter Phase I Clinical Trial to Assess the Safety of Two Consecutive Days of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma
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 Phase II clinical trial.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aichi
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Nagoya-city, Aichi, Japan
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Kanagawa
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Isehara-city, Kanagawa, Japan
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Kyoto
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Kyoto-city, Kyoto, Japan
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Tokyo
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Chuo-ku, Tokyo, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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 Criteria:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose-limiting toxicity
Time Frame: Treatment period
|
Treatment period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CR rate and the overall response rate, determination by Independent Review Committee
Time Frame: Treatment period
|
Treatment period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (ACTUAL)
March 1, 2010
Study Completion (ACTUAL)
May 1, 2010
Study Registration Dates
First Submitted
November 18, 2008
First Submitted That Met QC Criteria
November 19, 2008
First Posted (ESTIMATE)
November 20, 2008
Study Record Updates
Last Update Posted (ACTUAL)
July 2, 2021
Last Update Submitted That Met QC Criteria
July 1, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Lymphoma, Mantle-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Immunological
- Bendamustine Hydrochloride
- Rituximab
Other Study ID Numbers
- 2008002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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