Trials / Completed
CompletedNCT00612183
Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- Sponsor
- SymBio Pharmaceuticals · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | bendamustine hydrochloride | bendamustine hydrochloride is administered by 60-min drip infusion at 120 mg/m2/day for 2 consecutive days, and the course is then observed for 19 days. This is one cycle and administration is repeated for 3 - 6 cycles. From the second cycle, the dose is reduced or administration is discontinued as required based on adverse events observed in the previous cycle or observation of the course. |
Timeline
- Start date
- 2007-12-01
- Primary completion
- 2009-09-01
- Completion
- 2009-09-01
- First posted
- 2008-02-11
- Last updated
- 2010-07-22
Locations
17 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00612183. Inclusion in this directory is not an endorsement.