Back to resultsStudy to Evaluate the Safety of Subcutaneous Alemtuzumab in Patients With B-Cell Chronic Lymphocytic Leukemia
Primary Purpose
B-CLL
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
alemtuzumab
Sponsored by
About this trial
This is an interventional treatment trial for B-CLL
Eligibility Criteria
Inclusion Criteria: B-CLL that has failed fludarabine Exclusion Criteria: Performance status grade 3
Sites / Locations
- Dept. of Hematology, Karolinska University Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00162851
First Posted
September 8, 2005
Last Updated
July 23, 2007
Sponsor
Karolinska University Hospital
Collaborators
Schering Nordiska AB
1. Study Identification
Unique Protocol Identification Number
NCT00162851
Brief Title
Study to Evaluate the Safety of Subcutaneous Alemtuzumab in Patients With B-Cell Chronic Lymphocytic Leukemia
Official Title
A Pilot Study to Evaluate the Safety of Subcutaneous Alemtuzumab (MabCampath, Campath) in Patients With B-Cell Chronic Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Karolinska University Hospital
Collaborators
Schering Nordiska AB
4. Oversight
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-CLL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
alemtuzumab
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
B-CLL that has failed fludarabine
Exclusion Criteria:
Performance status grade 3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders C Osterborg, Professor
Organizational Affiliation
Dept. of Hematology, Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Hematology, Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
SE-171 76
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Safety of Subcutaneous Alemtuzumab in Patients With B-Cell Chronic Lymphocytic Leukemia
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