- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00587847
Campath Maintenance in Chronic Lymphocytic Leukemia
September 16, 2015 updated by: Kanti Rai, MD, Northwell Health
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New Hyde Park, New York, United States, 11040
- Long Island Jewish Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
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Campath 30 mg administered subcutaneously at varying intervals for up to 1 year
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Progression (Months)
Time Frame: Every 8 weeks
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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.
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Every 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Infections
Time Frame: Weekly then every 2 weeks then every 3 weeks
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Number of participants who developed clinical or laboratory evidence of infection.
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Weekly then every 2 weeks then every 3 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kanti R. Rai, MD, Long Island Jewish Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
January 7, 2008
First Posted (Estimate)
January 8, 2008
Study Record Updates
Last Update Posted (Estimate)
October 15, 2015
Last Update Submitted That Met QC Criteria
September 16, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05.10.030
- Berlex Study# 106.0621 (Other Identifier: Berlex)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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OHSU Knight Cancer InstituteOregon Health and Science UniversityCompletedRefractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); Celgene CorporationTerminatedChronic Lymphocytic Leukemia | B-cell Chronic Lymphocytic Leukemia | Stage 0 Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic LeukemiaUnited States
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Mayo ClinicNational Cancer Institute (NCI)CompletedChronic Lymphocytic Leukemia | Stage III Small Lymphocytic Lymphoma | Stage IV Small Lymphocytic Lymphoma | Stage 0 Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage I Small Lymphocytic Lymphoma | Stage III Chronic Lymphocytic Leukemia and other conditionsUnited States
Clinical Trials on Campath
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M.D. Anderson Cancer CenterLeudositeTerminatedLymphoma, B-Cell | Lymphoma, T-Cell | Lymphoma, Low-Grade | Leukemia, Lymphocytic, Acute | Leukemia, Lymphocytic, ChronicUnited States
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M.D. Anderson Cancer CenterTerminated
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M.D. Anderson Cancer CenterBerlex Laboratories, Inc.CompletedChronic Lymphocytic LeukemiaUnited States
-
Northwestern UniversityGenzyme, a Sanofi Company; Millennium Pharmaceuticals, Inc.Completed
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Fondazione IRCCS Istituto Nazionale dei Tumori,...CompletedLymphoma, T-Cell, PeripheralItaly
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M.D. Anderson Cancer CenterBayerCompletedChronic Lymphocytic LeukemiaUnited States
-
M.D. Anderson Cancer CenterGenzyme, a Sanofi CompanyTerminated
-
M.D. Anderson Cancer CenterActive, not recruitingRecurrent T-Cell Prolymphocytic Leukemia | T-Cell Prolymphocytic LeukemiaUnited States
-
Genzyme, a Sanofi CompanyTerminatedHematologic MalignanciesUnited States