A Phase I Study of Bendamustine Hydrochloride in Patients With Indolent B-Cell Non-Hodgkin's Lymphoma
The purpose of this study is to assess the tolerability, pharmacokinetics and antitumor effect of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell Non-Hodgkin's Lymphoma.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Hematological toxicity; > grade four (CTCAE v.3.0), during the treatment cycle (twenty one days)
- Non-Hematological toxicity; > grade three(CTCAE v.3.0), during the treatment cycle (twenty one days)
- All adverse events or adverse reactions, during the treatment cycle (twenty one days)
- Pharmacokinetics profile
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||September 2007|
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.