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
  Purpose
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.

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 Northwell Health:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 12
Study Start Date: August 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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
  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
Northwell Health
Bayer
Investigators
Principal Investigator: Kanti R. Rai, MD Long Island Jewish Medical Center
  More Information

Responsible Party: Kanti Rai, MD, Principal Investigator, 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
Results First Received: May 29, 2013
Last Updated: September 16, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwell Health:
leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Alemtuzumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 21, 2016