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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.
Sponsor:
Information provided by:
SymBio Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00612183
First received: January 28, 2008
Last updated: July 21, 2010
Last verified: May 2010
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

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] ] [ Designated as safety issue: No ]

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] ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00612183

Locations
Japan
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
Investigators
Study Chair: Kensei Tobinai, MD, PhD National Cancer Center Hospital
  More Information

No publications provided by SymBio Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Katsuhisa Goto, SymBio Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT00612183     History of Changes
Other Study ID Numbers: 2007002
Study First Received: January 28, 2008
Last Updated: July 21, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on May 19, 2013