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

NCT ID: NCT00612183

Last Updated: 2010-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-09-30

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.

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.

Conditions

Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SymBio Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

SymBio Pharmaceuticals Limited

Principal Investigators

Kensei Tobinai, MD, PhD

Role: STUDY_CHAIR

National Cancer Center Hospital

Locations

Nagoya, Aichi-ken, Japan

Kashiwa, Chiba, Japan

Fukuoka, Fukuoka, Japan

Sapporo, Hokkaido, Japan

Kagoshima, Kagoshima-ken, Japan

Isehara, Kanagawa, Japan

Kumamoto, Kumamoto, Japan

Kyoto, Kyoto, Japan

Sendai, Miyagi, Japan

Nagoya, Nagoya, Japan

Moriguchi, Osaka, Japan

Hamamatsu, Shizuoka, Japan

Utsunomiya, Tochigi, Japan

Chūō, Tokyo, Japan

Koto, Tokyo, Japan

Shibuya City, Tokyo, Japan

Shinagawa, Tokyo, Japan

Countries

Japan

References

Ohmachi K, Ando K, Ogura M, Uchida T, Itoh K, Kubota N, Ishizawa K, Yamamoto J, Watanabe T, Uike N, Choi I, Terui Y, Usuki K, Nagai H, Uoshima N, Tobinai K; Japanese Bendamustine Lymphoma Study Group. Multicenter phase II study of bendamustine for relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma. Cancer Sci. 2010 Sep;101(9):2059-64. doi: 10.1111/j.1349-7006.2010.01635.x.

Reference Type: DERIVED

PMID: 20626754 (View on PubMed)

Other Identifiers

2007002

Identifier Type: -

Identifier Source: org_study_id