Expired Study
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New Hyde Park, New York 11040


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT00587847


Primary Contact:

Principal Investigator
Kanti R. Rai, MD
Long Island Jewish Medical Center


Backup Contact:

N/A


Location Contact:

New Hyde Park, New York 11040
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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