Trials / Completed
CompletedNCT00923182
A Safety Confirmatory Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
A Japanese Phase I Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to confirm the safety profile of alemtuzumab 30 mg (the US/European Union (EU) approved dose) in Japanese patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL).
Detailed description
NOTE: This study was previously posted by Bayer. In December 2009, this study was acquired by Genzyme Corporation. Genzyme Japan K.K. is the sponsor of the trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | alemtuzumab |
Timeline
- Start date
- 2010-02-01
- Primary completion
- 2011-08-01
- Completion
- 2011-08-01
- First posted
- 2009-06-18
- Last updated
- 2015-04-30
Locations
6 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00923182. Inclusion in this directory is not an endorsement.