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

This study has been completed.
Information provided by:
SymBio Pharmaceuticals Identifier:
First received: January 28, 2008
Last updated: July 21, 2010
Last verified: May 2010
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 Intervention Phase
Non-Hodgkin's Lymphoma Mantle Cell Lymphoma Drug: bendamustine hydrochloride Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by SymBio Pharmaceuticals:

Primary Outcome Measures:
  • 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:
  • 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] ]

Estimated Enrollment: 56
Study Start Date: December 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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.
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.

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: January 28, 2008
Last Updated: July 21, 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 processed this record on September 25, 2017