Campath Maintenance in Chronic Lymphocytic Leukemia

This study has been terminated.
(Insufficient recruitment.)
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Kanti Rai, MD, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00587847
First received: December 21, 2007
Last updated: September 16, 2015
Last verified: September 2015

December 21, 2007
September 16, 2015
August 2005
November 2009   (final data collection date for primary outcome measure)
Time to Progression (Months) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
Time to progression calculated as the period, in months, between the date of the first dose of alemtuzumab and the first date of documented disease progression (NCI 1996 criteria) or death. Duration of response of all other participants who did not progress nor expire, had their event times calculated at the last date of follow-up.
Time to progression [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
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 3 weeks ] [ Designated as safety issue: Yes ]
Number of participants who developed clinical or laboratory evidence of infection.
Rate of Infections [ Time Frame: Weekly then every 2 weeks then every weeks ] [ Designated as safety issue: Yes ]
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 campath (also known as 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 Campath (also known as 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
Campath maintenance treatment
Single arm, open label trial of Campath on a maintenance schedule for patients who have had a response to prior conventional chemotherapy. Treatments consist of dose escalation (3, 10 and 30mg) during week 1 followed by weekly dosing of Campath at 30 mg once weekly for 7 weeks followed by Campath 30 mg every 2 weeks for 16 weeks followed by Campath 30 mg once every 3 weeks for 24 weeks. Total duration of treatment up to 48 weeks.
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 chronic lymphocytic leukemia, 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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587847
05.10.030, Berlex Study# 106.0621
No
Not Provided
Not Provided
Kanti Rai, MD, North Shore Long Island Jewish Health System
Northwell Health
Bayer
Principal Investigator: Kanti R. Rai, MD Long Island Jewish Medical Center
Northwell Health
September 2015

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