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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)

Phase 2
20 Years
75 Years
Not Enrolling
Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma

Thank you

Trial Information

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)

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.

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]

Outcome Time Frame:

[Treatment period]

Safety Issue:


Principal Investigator

Kensei Tobinai, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Center Hospital


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

December 2007

Completion Date:

September 2009

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Mantle Cell Lymphoma
  • non-Hodgkin's lymphoma
  • mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Mantle-Cell