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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00612183
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : July 22, 2010
Information provided by:
SymBio Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Mantle Cell Lymphoma Drug: bendamustine hydrochloride Phase 2

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  (Clinical Trial)
Estimated Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : December 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Intervention Details:
    Drug: bendamustine hydrochloride
    bendamustine hydrochloride is administered by 60-min drip infusion at 120 mg/m2/day for 2 consecutive days, and the course is then observed for 19 days. This is one cycle and administration is repeated for 3 - 6 cycles. From the second cycle, the dose is reduced or administration is discontinued as required based on adverse events observed in the previous cycle or observation of the course.

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

Secondary Outcome Measures :
  1. 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] ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00612183

Nagoya, Aichi, Japan
Kashiwa, Chiba, Japan
Sapporo, Hokkaido, Japan
Isehara, Kanagawa, Japan
Sendai, Miyagi, Japan
Moriguchi, Osaka, Japan
Hamamatsu, Shizuoka, Japan
Utsunomiya, Tochigi, Japan
Chuo, Tokyo, Japan
Koto, Tokyo, Japan
Shibuya, Tokyo, Japan
Shinagawa, Tokyo, Japan
Fukuoka, Japan
Kagoshima, Japan
Kumamoto, Japan
Kyoto, Japan
Nagoya, Japan
Sponsors and Collaborators
SymBio Pharmaceuticals
Study Chair: Kensei Tobinai, MD, PhD National Cancer Center Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Katsuhisa Goto, SymBio Pharmaceuticals Limited Identifier: NCT00612183     History of Changes
Other Study ID Numbers: 2007002
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: May 2010

Keywords provided by SymBio Pharmaceuticals:
non-Hodgkin's lymphoma
mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine Hydrochloride
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents