Back to Search

Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

RecruitingPhase 2
1 recruiting sites
Start: Dec 14, 2006
NCTNCT00412594

This trial is currently recruiting participants

1 location available for registration

Brief 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

Age Range

18 Years - N/A

Gender

All

Healthy Volunteers

Not Accepted

Detailed 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)

Conditions

Hairy Cell LeukemiaRecurrent Hairy Cell Leukemia

Interventions

Cladribine

Given IV

DRUG

Laboratory Biomarker Analysis

Correlative studies

OTHER

Rituximab

Given IV

BIOLOGICAL

Trial Locations

1 location currently accepting registrations. Choose a recruiting location below to register your interest.

M D Anderson Cancer Center

Houston, Texas, United States

Recruiting

Sponsor Information

Lead Sponsor

M.D. Anderson Cancer Center

Type: OTHER