Back to resultsCampath Maintenance in Chronic Lymphocytic Leukemia
Primary Purpose
Chronic Lymphocytic Leukemia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Campath
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring leukemia
Eligibility 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
Sites / Locations
- Long Island Jewish Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Campath maintenance treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
Time to Progression (Months)
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
Number of participants who developed clinical or laboratory evidence of infection.
Full Information
NCT ID
NCT00587847
First Posted
December 21, 2007
Last Updated
September 16, 2015
Sponsor
Northwell Health
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT00587847
Brief Title
Campath Maintenance in Chronic Lymphocytic Leukemia
Official Title
Maintenance Alemtuzumab in Refractory Chronic Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment.
Study Start Date
August 2005 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Campath maintenance treatment
Arm Type
Other
Arm Description
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 Type
Drug
Intervention Name(s)
Campath
Other Intervention Name(s)
Alemtuzumab
Intervention Description
Campath 30 mg administered subcutaneously at varying intervals for up to 1 year
Primary Outcome Measure Information:
Title
Time to Progression (Months)
Description
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 Frame
Every 8 weeks
Secondary Outcome Measure Information:
Title
Rate of Infections
Description
Number of participants who developed clinical or laboratory evidence of infection.
Time Frame
Weekly then every 2 weeks then every 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kanti R. Rai, MD
Organizational Affiliation
Long Island Jewish Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Campath Maintenance in Chronic Lymphocytic Leukemia
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