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Brief Title: Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma
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 ID: NCT00612183
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.
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, 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
Name: Kensei Tobinai, MD, PhD
Affiliation: National Cancer Center Hospital
Role: STUDY_CHAIR