Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: Genentech, Inc.; National Cancer Institute (NCI)
• Treatments: 2-chloro-3'-deoxyadenosine; Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Cladribine; Immunoglobulins; Rituximab

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)