Clinical Trial: Alemtuzumab (Campath ) to Treat T-Large Granular Lymphocyte Leukemia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders With Alemtuzumab (Campath)

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 and platelets, and increased numbers of abnormal cells called large granular lymphocytes (LGLs). Patients may have recurrent infections, anemia, or abnormal bleeding. Campath destroys specific parts of the abnormal LGLs, which interfere with the production of normal blood cells. This study will determine whether Campath can increase blood counts and reduce the number of abnormal LGLs in patients and will examine the side effects of the drug.

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 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  • Bone marrow biopsy: About a tablespoon of bone marrow is withdrawn through a needle inserted into the hipbone.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

    Detailed Summary:

    T Cell Large Granular Lymphocyte (T-LGL) lymphoproliferative disorders are a heterogeneous group of uncommon diseases which may involve a polyclonal or a monoclonal T cell population, which bear characteristic surface markers corresponding to activated cytotoxic (CD3+, CD8+) lymphocytes. They are often associated with quite severe neutropenia, anemia, and thrombocytopenia, which may be life-threatening. There is some evidence that the abnormal cytotoxic lymphocyte population may cause the cytopenias by suppressing hematopoiesis, although the mechanism is unclear. Immunosuppressive therapy has been shown to improve the cytopenias of T-LGL leukemia, however the long term use of the commonly used agents often lead to significant toxicity in the older patients which are affected by this disease.

    Alemtuzumab (Campath[R]) is currently approved as second line agent in patients with chronic lymphocytic leukemia (CLL) and has been used successfully in the treatment of certain autoimmune disorders. In the Hematology Branch, Campath is currently being investigated in two bone marrow failure syndromes: aplastic anemia and myelodysplasia. Cytopenia(s) is an important characteristic of patients with T-LGL leukemia, often being the indication for immunosuppressive therapy. Our preliminary experience with Campath indicates that it is well tolerated, in particular among the elderly patients.

    Therefore, we propose this pilot, Phase II, single agent, study which will evaluate the efficacy and safety of alemtuzumab (Campath[R]), an immunosuppressive drug, in subjects with T-LGL leukemia. Commercially available aAlemtuzumab (Campath[R]) will be administered off label at 10 mg per day by intravenous infusion for 10 days total. Subjects who do not show a response to initial Campath or relapse may receive a second cycle of drug after the 3 month
    Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

    Current Primary Outcome: The primary end point of the study is the response rate at three months, defined as improvement in cytopenia(s) [ Time Frame: 3 months ]

    Original Primary Outcome:

    Current Secondary Outcome: Secondary endpoints will include relapse-free survival, response at 6 months, life threatening toxicity, reduction in the number of abnormal T-LGL clone, and overall survival. [ Time Frame: Months/years ]

    Original Secondary Outcome:

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: June 27, 2006
    Date Started: June 20, 2006
    Date Completion: December 31, 2019
    Last Updated: May 17, 2017
    Last Verified: May 16, 2017