Study to Evaluate the Safety of Subcutaneous Alemtuzumab in Patients With B-Cell Chronic Lymphocytic Leukemia
Sponsor
Karolinska University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00162851
Collaborator
Schering Nordiska AB (Other)
20
1
39
0.5
Study Details
Study Description
Brief Summary
This is a Phase II trial to study the safety and tolerability of subcutaneous alemtuzumab administered without dose escalation to patients with advanced B-cell chronic lymphocytic leukemia (B-CLL).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
20 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study to Evaluate the Safety of Subcutaneous Alemtuzumab (MabCampath, Campath) in Patients With B-Cell Chronic Lymphocytic Leukemia
Study Start Date
:
Apr 1, 2003
Actual Study Completion Date
:
Jul 1, 2006
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- B-CLL that has failed fludarabine
Exclusion Criteria:
- Performance status grade 3
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dept. of Hematology, Karolinska University Hospital | Stockholm | Sweden | SE-171 76 |
Sponsors and Collaborators
- Karolinska University Hospital
- Schering Nordiska AB
Investigators
- Principal Investigator: Anders C Osterborg, Professor, Dept. of Hematology, Karolinska University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00162851
Other Study ID Numbers:
- CAM219
First Posted:
Sep 13, 2005
Last Update Posted:
Jul 25, 2007
Last Verified:
Aug 1, 2005
Additional relevant MeSH terms: