Who is eligible for clinical trial NCT00412594?

Participants must meet protocol criteria for Hairy Cell Leukemia. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT00412594 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-09

Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia (NCT00412594)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: M.D. Anderson Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (7 items).

Location: M D Anderson Cancer Center — Houston, Texas

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

M D Anderson Cancer Center — Houston, Texas

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗