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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hematological toxicity; > grade four (CTCAE v.3.0), during the treatment cycle (twenty one days)
Kensei Tobinai, MD, PhD
Study Chair
National Cancer Center Hospital
Japan: Ministry of Health, Labor and Welfare
2006001
NCT00389051
October 2006
September 2007
Name | Location |
---|