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A Multicenter, Open Study to Assess the Tolerability, Pharmacokinetics and Antitumor Effect of Bendamustine Hydrochloride (SyB L-0501: 90 or 120 mg/m2/Day) Administered Intravenously for Two Days in Patients With Indolent Lymphoma


Phase 1
20 Years
75 Years
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

A Multicenter, Open Study to Assess the Tolerability, Pharmacokinetics and Antitumor Effect of Bendamustine Hydrochloride (SyB L-0501: 90 or 120 mg/m2/Day) Administered Intravenously for Two Days in Patients With Indolent Lymphoma


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 indolent B-cell Non-hodgkin's lymphoma.


Inclusion Criteria:



Indolent B cell 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.

- Patients who had not received treatment (chemotherapy, antibody therapy and
radiation/ radiotherapy) for more than 4 weeks following prior therapy and who are
judged to carry no effect from the prior therapy.

- Patients aged from 20 to less than 75 years.

- Patients who had agreed in-patient during first course therapy.

- 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 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:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Hematological toxicity; > grade four (CTCAE v.3.0), during the treatment cycle (twenty one days)

Principal Investigator

Kensei Tobinai, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Center Hospital

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

2006001

NCT ID:

NCT00389051

Start Date:

October 2006

Completion Date:

September 2007

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Malignant lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

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