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2CDA With Rituximab in Hairy Cell Leukemia
Conditions
Leukemia
Conditions: official terms
Leukemia - Leukemia, Hairy Cell
Conditions: Keywords
Hairy Cell Leukemia, Leukemia, 2CDA, 2-chlorodeoxyadenosine, Rituximab, Rituxan, HCL
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cladribine
Type: Drug
Name: Rituximab
Type: Drug
Overall Status
Recruiting
Summary
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.
Detailed Description
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
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)
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
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)
Location
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Start Date
September 2004
Sponsors
M.D. Anderson Cancer Center
Source
M.D. Anderson Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page