Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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

You cannot join if

• 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)

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

cladribine. A purine nucleoside antimetabolite analogue. Cladribine triphosphate, a phosphorylated metabolite of cladribine, incorporates into DNA, resulting in single-strand breaks in DNA, depletion of nicotinamide adenine dinucleotide (NAD) and adenosine triphosphate (ATP), and apoptosis. Because this agent is resistant to adenosine deaminase, an enzyme that inactivates some antineoplastic agents, it is selectively toxic to lymphocytes and monocytes which exhibit little deoxynucleotide deaminase activity. NCI Drug Dictionary

R-CHOP regimen. A regimen consisting of cyclophosphamide, doxorubicin, prednisone, rituximab and vincristine that may be used for the treatment of AIDS-related B-cell lymphomas, Castleman disease, chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, gastric and nongastric MALT lymphomas, nodular lymphocyte-predominant Hodgkin lymphoma, mantle cell Lymphoma, nodal marginal zone lymphoma (NMZL), splenic marginal zone lymphoma (SMZL), Waldenström macroglobulinemia and lymphoplasmacytic lymphoma, and post-transplant lymphoproliferative disorders. NCI Drug Dictionary

Treatments listed in the registry

• Cladribine (Drug): Given IV
• Laboratory Biomarker Analysis (Other): Correlative studies
• Rituximab (Biological): Given IV

Na · Single Group · masking: None

Main goals

• Efficacy of rituximab on achievement of complete response after therapy with cladribine (At 12 weeks)
• Monitoring the related toxicity for the therapy Grade 3-4 (Up to 1 year)
• Efficacy of rituximab in eradication of minimal residual disease after cladribine therapy, assessed by immunophenotyping of bone marrow and peripheral blood (Up to 4 weeks after the last dose of rituximab)
• Efficacy of rituximab on prolongation of event-free survival (Up to 1 year)
• Efficacy of rituximab on prolongation of overall survival (Up to 1 year)

Planned enrollment: 150 (estimated).

• M D Anderson Cancer Center, Houston, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

These papers are listed in the registry record. Unless a paper is marked as about this trial, it is background research on the treatment or disease, not results from this study.

• Publication about this trial (to be verified before citing)Ravandi F, O'Brien S, Jorgensen J, Pierce S, Faderl S, Ferrajoli A, Koller C, Challagundla P, York S, Brandt M, Luthra R, Burger J, Thomas D, Keating M, Kantarjian H. Phase 2 study of cladribine followed by rituximab in patients with hairy cell leukemia. Blood. 2011 Oct 6;118(14):3818-23. doi: 10.1182/blood-2011-04-351502. Epub 2011 Aug 5.

• ClinicalTrials.gov NCT00412594
• NCI Drug Dictionary: C1336
• NCI Drug Dictionary: C1702

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jun 10, 2026. Public record; not medical advice.