Protocol Number: 09-C-0005
- Cladribine is very effective in treating hairy cell leukemia, but it is not known if it can cure the disease. - Rituximab is a monoclonal antibody that binds to the hairy cells and may kill them either by causing the cells to kill themselves or by getting the immune system to kill the cells. Rituximab is effective in hairy cell leukemia but is not considered standard treatment. Rituximab is approved by the Food and Drug Administration to treat patients with follicular non-Hodgkin's Lymphoma and diffuse large B-cell non-Hodgkin's lymphoma and for certain patients with rheumatoid arthritis. Objectives: - To determine if cladribine and rituximab, whether given together or with rituximab given 6 months after cladribine, is effective in treating residual hair cell leukemia (disease that remains after the original treatment).
Eligibility: - Patients 18 years of age and older with hair cell leukemia. - Patients who have received no more than one prior course of cladribine and no prior treatment with rituximab. Design: - It is believed that Rituximab may improve the activity of cladribine in cladribine, but it is unknown whether it would help most to add it at the beginning or wait until 6 months when the cladribine has had a full chance to work. Therefore, patients are randomly assigned to receive rituximab at the same time as cladribine or to receive the rituximab at least 6 months after cladribine (and only if hairy cells are present in a blood or bone marrow biopsy). - Patients receive the initial treatment during a 5- to 7-day hospitalization at the NIH Clinical Center. Cladribine is given by vein over 2 hours every day for 5 days. Rituximab is given through a vein over 2 hours (or longer, if needed) once a week for 8 weeks. - Patients have several lab tests, including bone marrow biopsies and blood tests, to determine whether they have hairy cells left during or after treatment. - CT or other imaging study of the spleen and any other site of disease at 1 and 6 months after cladribine; before and 6 months after beginning delayed rituximab, yearly for 4 years while in complete remission, then every 2 years after that while in complete remission.
Search The Studies | Help | Questions |
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009
|
||