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Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders with Alemtuzumab (Campath)
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
06-H-0190 |
Sponsoring Institute |
National Heart, Lung and Blood Institute (NHLBI) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Special Instructions |
Currently Not Provided |
Keywords |
Neutropenia; |
Recruitment Keyword(s) |
LGL Leukemia; |
Condition(s) |
Lymphoproliferative Disorders |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
Drug: Alemtuzumab (Campath) |
Supporting Site |
|
Patients 18 to 85 years of age with T-LGL leukemia may be eligible for this study. Participants undergo the following procedures:
Before starting Campath(Registered Trademark) treatment
-Medical history and physical examination, blood tests, electrocardiogram (ECG).
-Echocardiogram (heart ultrasound) and 24-hour Holter monitoring (continuous ECG recording).
-Bone marrow biopsy: About a tablespoon of bone marrow is withdrawn through a needle inserted into the hipbone. The procedure is done using local anesthetic.
-Placement of central line, if needed: An intravenous line (tube) is placed into a major vein in the chest. It can stay in the body and be used for the entire treatment period. The line is used to give chemotherapy or other medications, including antibiotics and blood transfusions, and to collect blood samples. The line is usually placed under local anesthesia in the radiology department or the operating room.
-Apheresis: A catheter (plastic tube) is placed in a vein in each arm. Blood is drawn from one vein and run through a cell-separating machine, where the white blood cells are collected and saved. The remaining blood is transfused back to the patients through the vein in the other arm.
During Campath(Registered Trademark) treatment
-Campath(Registered Trademark) therapy: After a small test dose, patients receive10 daily infusions of Campath(Registered Trademark), each of which lasts about 2 hours. The first few infusions are given at the NIH Clinical Center so that the patient can be monitored closely.
-Induction therapy: Aerosolized pentamadine, valacyclovir and other medicines are given to protect against or treat various infections that commonly affect patients with suppressed immune systems.
-Whole blood or platelet transfusions, if needed, and injections of growth factors, if needed.
-Blood tests and check of vital signs (temperature, pulse, blood pressure) every day during treatment. Echocardiogram and 24-hour Holter monitor after the last dose of Campath(Registered Trademark).
Follow-up evaluations after Campath(Registered Trademark) treatment ends
-Blood tests at home or at NIH (weekly for the first 3 months, then every other week until 6 months, then annually for 5 years
-Echocardiogram at NIH (at 3 months only)
-Bone marrow biopsy at NIH (at 6 and 12 months, then as clinically indicated)
-One repeat apheresis collection for laboratory studies.
Eligibility
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.
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information http://clinicalstudies.info.nih.gov. |
| Bogdan Dumitriu, M.D. National Institutes of Health Clinical Center (CC) National Institutes of Health Building 10 Room 2C145 10 Center Drive Bethesda, Maryland 20892 (301) 496-9320 hmasur@cc.nih.gov |
Olga J. Rios, R.N. National Institutes of Health Clinical Center (CC) National Institutes of Health Building 10 Room 2C145 10 Center Drive Bethesda, Maryland 20892 (301) 496-9320 hmasur@cc.nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT00345345
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