Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma

July 21, 2010 updated by: SymBio Pharmaceuticals

Phase II Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma (Multicenter, Open-label Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, vincristine and prednisolone). After the approval of an antibody therapy agent Rituximab®, it alone or combination with CHOP has been introduced. Bendamustine hydrochloride has a unique structure compared with the marketed agents, and has an innovative mechanism of action. Thus, it is expected that Bendamustine hydrochloride will provide new alternatives for patients with refractory/recurrent indolent B-cell Non-hodgkin's lymphoma.

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 2

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

  • Japan
      • Fukuoka, Japan
      • Kagoshima, Japan
      • Kumamoto, Japan
      • Kyoto, Japan
      • Nagoya, Japan
    • Aichi
      • Nagoya, Aichi, Japan
    • Chiba
      • Kashiwa, Chiba, Japan
    • Hokkaido
      • Sapporo, Hokkaido, Japan
    • Kanagawa
      • Isehara, Kanagawa, Japan
    • Miyagi
      • Sendai, Miyagi, Japan
    • Osaka
      • Moriguchi, Osaka, Japan
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan
    • Tochigi
      • Utsunomiya, Tochigi, Japan
    • Tokyo
      • Chuo, Tokyo, Japan
      • Koto, Tokyo, Japan
      • Shibuya, Tokyo, Japan
      • Shinagawa, Tokyo, Japan

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:

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 Criteria:

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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]
Time Frame: [Treatment period]
[Treatment period]

Secondary Outcome Measures

Outcome Measure
Time Frame
CR rate of overall results based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]
Time Frame: [Treatment Period]
[Treatment Period]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SymBio Pharmaceuticals

Investigators

  • Study Chair: Kensei Tobinai, MD, PhD, National Cancer Center Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

January 28, 2008

First Submitted That Met QC Criteria

January 28, 2008

First Posted (Estimate)

February 11, 2008

Study Record Updates

Last Update Posted (Estimate)

July 22, 2010

Last Update Submitted That Met QC Criteria

July 21, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007002

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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