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2CDA With Rituximab in Hairy Cell Leukemia - NCT00412594-77030(Clinical Trial 157374)



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City:  Houston
State:  
TX
Zip Code: 77030
Conditions: Leukemia
Purpose: The goal of this clinical research study is to learn if treatment with 2CDA (cladribine) followed by treatment with rituximab can help to control HCL. The safety of this combination treatment will also be studied. Objectives: 1. To demonstrate the efficacy in achieving complete response of combination of Cladribine administered intravenously over 2 hours for 5 days followed by Rituximab weekly for 8 weeks in patients with untreated or previously treated hairy cell leukemia. 2. To examine the efficacy of Rituximab to eradicate minimal residual disease (MRD) after Cladribine therapy (as assessed by immunophenotyping of bone marrow and peripheral blood). 3. To examine the effect of addition of Rituximab to Cladribine on the long term disease-free (DFS) and overall survival (OS)(as compared with historical controls)
Study summary: Cladribine is a chemotherapy drug that has been used for over 10 years to treat HCL with very good results and very low rate of side effects. Rituximab is an antibody protein that targets a specific molecule on the surface of cancer cells in order to eliminate them. It has been used for over 5 years to treat a number of cancers of blood and lymph nodes and has been used with some success to treat patients with HCL whose disease has returned after a previous remission. Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam. Blood (about 3 teaspoons) will be drawn for routine tests. You will have a bone marrow biopsy as well. To collect a bone marrow biopsy, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must have a negative blood pregnancy test. If you are found to be eligible to take part in this study, you will receive cladribine by vein over 2 hours once a day for 5 days in a row. You will only receive 1 cycle (5 days) of this treatment. Then you will receive rituximab by vein once a week for 8 weeks. Treatment with rituximab will start around Day 28. After the first dose of each study drug has been given to you at M. D. Anderson, all later doses of both drugs can be given to you by your community doctor in your home town. You will have a weekly blood tests (about 1 teaspoon each) for the first 4 weeks and before receiving rituximab. You will have a repeat bone marrow biopsy before starting rituximab in order to see how much disease is left behind. You will then have a blood test (about 1 teaspoon) every 2 to 4 weeks while you are receiving rituximab. A bone marrow biopsy will also be done at the end of rituximab treatment. You will be taken off the study if the disease gets worse or if intolerable side effects occur. After completing rituximab, you will return for a follow-up visit every 3 months for one year and then every 6-12 months for 2 years. At these visits you will have blood (about 1 teaspoon) tests performed. This is an investigational study. Both drugs are approved by the FDA and are commercially available. Their use together in this study, however, is experimental. A total of 74 patients will take part in this study. All will be enrolled at M. D. Anderson.
Criteria: Inclusion Criteria: 1. Age 18 years and older 2. Diagnosis of HCL established by bone marrow examination 3. Patients with relapsed disease are eligible if they have had no more than one prior therapy 4. Women of child-bearing potential must use birth control (oral contraceptive, barrier, abstinence or any other acceptable method) for the duration of the study 5. Performance status </= 3 6. Adequate renal function: creatinine less than or equal to 2.0 unless related to the disease 7. Adequate liver function: bilirubin less than or equal to 3.0, transaminases less than or equal 3 x upper limit of normal unless related to the disease 8. No prior investigational agent in the 4 weeks prior to initiation of therapy Exclusion Criteria: 1. Unable or unwilling to sign the consent form 2. Known infection with HIV, hepatitis B or C 3. Presence of active infection 4. Presence of CNS metastases 5. New York Heart Association Classification III or IV heart disease (See Appendix I) 6. Prior chemotherapy (last 4 weeks)
Study is available at: UT MD Anderson Cancer Center
Houston, TX 77030
United States

Primary Contact:
Farhad Ravandi-Kashani, MD
Phone: 713-792-7305
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 21, 2011
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