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

This study has been completed.
Sponsor:
Collaborator:
Schering Nordiska AB
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00162851
First received: September 8, 2005
Last updated: July 23, 2007
Last verified: August 2005
  Purpose

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 Intervention Phase
B-CLL
Drug: alemtuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Estimated Enrollment: 20
Study Start Date: April 2003
Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • B-CLL that has failed fludarabine

Exclusion Criteria:

  • Performance status grade 3
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162851

Locations
Sweden
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00162851     History of Changes
Other Study ID Numbers: CAM219
Study First Received: September 8, 2005
Last Updated: July 23, 2007
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Alemtuzumab
Campath 1G
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 14, 2014