Study to Evaluate the Safety of Subcutaneous Alemtuzumab in Patients With B-Cell Chronic Lymphocytic Leukemia

B-CLL Clinical Trial

Official title:

A Pilot Study to Evaluate the Safety of Subcutaneous Alemtuzumab (MabCampath, Campath) in Patients With B-Cell Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162851
• Other study ID #: CAM219
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: July 23, 2007
• Start date: April 2003
• Est. completion date: July 2006

Study information

• Verified date: August 2005
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• B-CLL that has failed fludarabine

Exclusion Criteria:

• Performance status grade 3

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B-CLL
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• alemtuzumab

Locations

Country	Name	City	State
Sweden	Dept. of Hematology, Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Schering Nordiska AB

Country where clinical trial is conducted

Sweden,