Clinical trial NCT00612183: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma
Keywords: non-Hodgkin's lymphoma
mantle cell lymphoma
Lead sponsor: SymBio Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-02-11
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Overall response rate based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]
timeFrame: [Treatment period]
Secondary outcomes:
measure: CR rate of overall results based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]
timeFrame: [Treatment Period]
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Kashiwa
country: Japan
state: Chiba
city: Sapporo
country: Japan
state: Hokkaido
city: Isehara
country: Japan
state: Kanagawa
city: Sendai
country: Japan
state: Miyagi
city: Moriguchi
country: Japan
state: Osaka
city: Hamamatsu
country: Japan
state: Shizuoka
city: Utsunomiya
country: Japan
state: Tochigi
city: Chuo
country: Japan
state: Tokyo
city: Koto
country: Japan
state: Tokyo
city: Shibuya
country: Japan
state: Tokyo
city: Shinagawa
country: Japan
state: Tokyo
city: Fukuoka
country: Japan
city: Kagoshima
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Nagoya
country: Japan
Study officials:
affiliation: National Cancer Center Hospital
name: Kensei Tobinai, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.