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Campath Maintenance in Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00587847
Recruitment Status : Terminated (Insufficient recruitment.)
First Posted : January 8, 2008
Results First Posted : October 15, 2015
Last Update Posted : October 15, 2015
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Kanti Rai, MD, Northwell Health

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Campath Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maintenance Alemtuzumab in Refractory Chronic Lymphocytic Leukemia
Study Start Date : August 2005
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Time to Progression (Months) [ Time Frame: Every 8 weeks ]
    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 :
  1. Rate of Infections [ Time Frame: Weekly then every 2 weeks then every 3 weeks ]
    Number of participants who developed clinical or laboratory evidence of infection.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00587847


Locations
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United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Northwell Health
Bayer
Investigators
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Principal Investigator: Kanti R. Rai, MD Long Island Jewish Medical Center
More Information
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Responsible Party: Kanti Rai, MD, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT00587847    
Other Study ID Numbers: 05.10.030
Berlex Study# 106.0621 ( Other Identifier: Berlex )
First Posted: January 8, 2008    Key Record Dates
Results First Posted: October 15, 2015
Last Update Posted: October 15, 2015
Last Verified: September 2015
Keywords provided by Kanti Rai, MD, Northwell Health:
leukemia
Additional relevant MeSH terms:
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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, Immunological
Antineoplastic Agents