2CDA With Rituximab in Hairy Cell Leukemia
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed By Rituximab in Hairy Cell Leukemia|
- Complete Response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Complete response (CR) defined as absence of hairy cells in the bone marrow (BM) or presence of less than 1% atypical cells (not definitively called hairy cells) and disappearance of all evidence of HCL on physical examination. Hematologic parameters for CR require an ANC of 1.5 x 109/L or greater; Hgb at least 12.0 g/dL (at least 11.0 g/dL for females); and PLT at least 100 x 109/L without growth factor or transfusion support. CR with residual disease (CR-RD) is defined as for CR but with persistence of 1% to 5% hairy cells in the marrow (but no circulating hairy cells).
|Study Start Date:||September 2004|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Experimental: 2CDA + Rituximab
Cladribine (2CDA) 5.6 mg/m^2 by vein over 2 hours daily for 5 days; Rituximab 375 mg/m^2 by vein weekly times 8 starting on day 28 (plus or minus 4 days) following 2CDA treatment.
5.6 mg/m^2 by vein over 2 hours daily for 5 days
Other Names:Drug: Rituximab
375 mg/m^2 by vein weekly x 8 starting on day 28 (plus or minus 4 days) following 2CDA treatment.
Other Name: Rituxan
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.
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 MD 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. 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 150 patients will take part in this study. All will be enrolled at MD Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412594
|Contact: Farhad Ravandi-Kashani, MD||713-792-7305|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Farhad Ravandi-Kashani, MD||M.D. Anderson Cancer Center|