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Spots Global Cancer Trial Database for Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

, 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

Contact Details

Name: Kensei Tobinai, MD, PhD

Affiliation: National Cancer Center Hospital

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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