Campath Maintenance in Chronic Lymphocytic Leukemia

This study has been terminated.
(Insufficient recruitment.)
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00587847
First received: December 21, 2007
Last updated: May 23, 2012
Last verified: May 2012

December 21, 2007
May 23, 2012
May 2005
November 2009   (final data collection date for primary outcome measure)
Time to progression [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00587847 on ClinicalTrials.gov Archive Site
Rate of infections [ Time Frame: Weekly then every 2 weeks then every weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Campath Maintenance in Chronic Lymphocytic Leukemia
Maintenance Alemtuzumab in Refractory Chronic Lymphocytic Leukemia

This is a study designed to test whether giving alemtuzumab on a maintenance schedule will prolong the time until the patient requires chemotherapy.

This is an open-label, single arm, proof-of-principle study of alemtuzumab maintenance therapy administered subcutaneously at varying intervals for up to 1 year. Ongoing prophylactic anti-infectives will be provided. Patients will be assessed for response every 2 months and for quality of life every 3 months while on treatment. Patients achieving a presumptive complete response will receive no further treatment but will be followed for response. Non-responding patients, with confirmed progressing disease following a minimum of 8 doses will be discontinued from treatment and followed for survival. Responding patients or patients with stable disease will undergo confirmatory assessment 2 months following their end-of-treatment assessment. If remission has occurred, patients will be followed off treatment until documented disease progression.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
Drug: Campath
Campath 30 mg administered subcutaneously at varying intervals for up to 1 year
Other Name: Alemtuzumab
Experimental: A
single arm, open label trial
Intervention: Drug: Campath
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Enrollment in this study is open to patients 18 years of age with confirmed CLL, a clinical response of stable disease or better to previous treatment, and an Eastern Cooperative Oncology Group performance status of 0-2

Exclusion Criteria:

  • Treatment failure in more than 3 prior regimens
  • Active secondary malignancy
  • Central nervous system involvement with CLL
  • History of significant allergic reaction to antibody therapies that required discontinuation of the antibody therapy
  • History of HIV positivity
  • Hepatitis C virus (HCV) positivity based upon core antigen testing
  • Active infection, requiring treatment with antibiotic, antiviral, or antifungal agents
  • Pregnancy or lactation
  • Other severe, concurrent diseases or mental disorders
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587847
05.10.030, Berlex Study# 106.0621
No
North Shore Long Island Jewish Health System
North Shore Long Island Jewish Health System
Bayer
Principal Investigator: Kanti R. Rai, MD Long Island Jewish Medical Center
North Shore Long Island Jewish Health System
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP