Home › Hairy Cell Leukemia › NCT00412594
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed by Rituximab in Hairy Cell Leukemia
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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)
About the study
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.
What is being tested
- Cladribine (drug)
- Laboratory Biomarker Analysis (other)
- Rituximab (biological)
Sponsor: M.D. Anderson Cancer Center · Participants: 150 · Started: Jun 10, 2004
Contact the study team
- Farhad Ravandi-Kashani · Phone: 713-792-7305
Official record on ClinicalTrials.gov — NCT00412594
Locations in the U.S.
| Texas | M D Anderson Cancer Center, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.