Trial record 15 of 2522 for:
non-Hodgkin's lymphoma
A Phase I Clinical Trial to Assess the Safety of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma
This study has been completed.
Sponsor:
SymBio Pharmaceuticals
Information provided by:
SymBio Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00794638
First received: November 18, 2008
Last updated: May 27, 2010
Last verified: May 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma Diffuse Large B-cell Lymphoma Mantle Cell Lymphoma Follicular Lymphoma |
Drug: SyB L-0501 Drug: Rituximab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by SymBio Pharmaceuticals:
Primary Outcome Measures:
- Dose-limiting toxicity [ Time Frame: Treatment period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- CR rate and the overall response rate, determination by Independent Review Committee [ Time Frame: Treatment period ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | November 2008 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: SyB L-0501
The administration of SyB L-0501 90 mg/m2 or 120 mg/m2/day on Day 2 and Day 3 will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation).
Other Name: Bendamustine hydrochloride
Drug: Rituximab
The administration of rituximab 375 mg/m2 on Day 1 of each cycle will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation).
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794638
Locations
| Japan | |
| Nagoya-city, Aichi, Japan | |
| Isehara-city, Kanagawa, Japan | |
| Kyoto-city, Kyoto, Japan | |
| Chuo-ku, Tokyo, Japan | |
Sponsors and Collaborators
SymBio Pharmaceuticals
Investigators
| Study Chair: | Kensei Tobinai, MD, Ph D | National Cancer Center Hospital |
More Information
No publications provided
| Responsible Party: | Masahiro Furukawa, SymBio Pharmaceuticals Limited |
| ClinicalTrials.gov Identifier: | NCT00794638 History of Changes |
| Other Study ID Numbers: | 2008002 |
| Study First Received: | November 18, 2008 |
| Last Updated: | May 27, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by SymBio Pharmaceuticals:
|
Non-Hodgkin's Lymphoma Diffuse Large B-Cell Lymphoma Mantle cell Lymphoma Transformed lymphoma, transformed to diffuse large B-cell lymphoma Follicular Lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Bendamustine Rituximab Nitrogen Mustard Compounds Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 23, 2013