Alemtuzumab (Campath) to Treat T-Large Granular Lymphocyte Leukemia
T-LGL Lymphoproliferative Disorders
About this trial
This is an interventional treatment trial for T-LGL Lymphoproliferative Disorders focused on measuring Neutropenia, Monoclonal Antibody Therapy, Anti-CD52, T-LGL Leukemia, LGL Leukemia, Leukemia
Eligibility Criteria
INCLUSION CRITERIA: Clinical history supportive of the diagnosis of T-LGL leukemia (i.e. a history of cytopenias with peripheral blood morphologic evidence of LGLs) Immunophenotypic studies of peripheral blood showing an increased population of T-LGLs (suggested by staining with CD3+, CD8+ and CD16+ or CD57+) or gammadelta T cells Restricted or clonal rearrangement of the T-cell receptor by PCR AND one or more of the following: Severe neutropenia (less than 500 neutrophils/microliter); OR Severe thrombocytopenia (less than 20,000 platelets/microliter), or moderate thrombocytopenia (less than 50,000 platelets/microliter) with active bleeding; OR Symptomatic anemia with a hemoglobin less than 9 g/dL or red blood cell transfusion requirement of greater than 2 units/month for two months prior to initiation of Campath Ages 18-85 (both inclusive) EXCLUSION CRITERIA: A reactive LGL lymphocytosis to a viral infection Serologic evidence of HIV infection Infection not adequately responding to appropriate therapy Previous immunosuppressive therapy with alemtuzumab History of carcinoma that is not considered cured (excluding non-melanoma skin carcinoma) Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the subject's ability to tolerate protocol therapy or that death within 7-10 days is likely Current pregnancy or unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential Not able to understand the investigational nature of the study or give informed consent.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Experimental
Alemtuzumab in patients with T cell large granular lymphocytic leukemia (T-LGL)
Alemtuzumab (Campath) will be administered at 10 mg/dose IV for 10 days as an infusion over 2 hours.