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
  Purpose

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


Condition Intervention
Chronic Lymphocytic Leukemia
Drug: Campath

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maintenance Alemtuzumab in Refractory Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Time to progression [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of infections [ Time Frame: Weekly then every 2 weeks then every weeks ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: May 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
single arm, open label trial
Drug: Campath
Campath 30 mg administered subcutaneously at varying intervals for up to 1 year
Other Name: Alemtuzumab

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587847

Locations
United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Bayer
Investigators
Principal Investigator: Kanti R. Rai, MD Long Island Jewish Medical Center
  More Information

No publications provided

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00587847     History of Changes
Other Study ID Numbers: 05.10.030, Berlex Study# 106.0621
Study First Received: December 21, 2007
Last Updated: May 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by North Shore Long Island Jewish Health System:
leukemia

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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014