Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed by Rituximab in Hairy Cell Leukemia
M.D. Anderson Cancer Center
150 participants
Jun 10, 2004
INTERVENTIONAL
Conditions
Summary
This phase II trial studies the side effects and how well cladribine and rituximab work in treating patients with hairy cell leukemia. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cladribine together with rituximab may kill more cancer cells.
Eligibility
Inclusion Criteria9
- Age 18 years and older
- Diagnosis of hairy cell leukemia (HCL) established by bone marrow examination
- Patients with relapsed disease are eligible if they have had no more than one prior therapy
- Women of child-bearing potential must use birth control (oral contraceptive, barrier, abstinence or any other acceptable method) for the duration of the study
- Performance status =\< 3
- Creatinine less than or equal to 2.0 unless related to the disease
- Bilirubin less than or equal to 3.0
- Transaminases less than or equal 3 x upper limit of normal unless related to the disease
- No prior investigational agent in the 4 weeks prior to initiation of therapy
Exclusion Criteria6
- Unable or unwilling to sign the consent form
- Known infection with human immunodeficiency virus (HIV), hepatitis B or C
- Presence of active infection
- Presence of central nervous system (CNS) metastases
- New York Heart Association classification III or IV heart disease
- Prior chemotherapy (last 4 weeks)
Interventions
Given IV
Correlative studies
Given IV
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT00412594