Status:
COMPLETED
Alemtuzumab (Campath) to Treat T-Large Granular Lymphocyte Leukemia
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
T-LGL Lymphoproliferative Disorders
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
This study will examine the use of alemtuzumab (Campath) in patients with T cell large granular lymphocytic leukemia (T-LGL). Patients with T-LGL often have reduced white blood cells, red blood cells ...
Detailed Description
T Cell Large Granular Lymphocyte (T-LGL) lymphoproliferative disorders are a heterogeneous group of uncommon diseases which may involve a monoclonal or oligoclonal T cell population, which bear charac...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 17 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2020
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00345345
Start Date
October 17 2006
End Date
October 27 2020
Last Update
May 3 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892