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Cladribine and Rituximab for Hairy Cell Leukemia

This study is looking at how well two drugs, cladribine and rituximab, work together to treat hairy cell leukemia (HCL). Cladribine is a chemotherapy drug that stops cancer cells from growing. Rituximab is an immunotherapy that helps your immune system attack cancer cells. Researchers want to see if giving these two drugs together can kill more cancer cells. You may be able to join if you are 18 or older, have HCL confirmed by a bone marrow exam, and have had no more than one prior treatment if your HCL has returned. The study will measure how many people have a complete response after treatment and how well rituximab gets rid of any remaining cancer cells. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 150 participants. It is a single-arm study, meaning all participants receive the same treatment.
What's involved
You would receive cladribine intravenously for 5 days, followed by rituximab intravenously once a week for 8 weeks. This treatment continues as long as your disease doesn't worsen or side effects are manageable.
Compensation
Not stated in the trial record.
Follow-up
After completing treatment, participants are followed up every 3 months for 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00412594

Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~150 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:CladribineLaboratory Biomarker AnalysisRituximab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy of rituximab on achievement of complete response after therapy with cladribine
Measured over At 12 weeks
+4 more outcomes measured

Conditions

Hairy Cell Leukemia
Recurrent Hairy Cell Leukemia

Explore related trials

Hairy Cell Leukemia

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Farhad Ravandi-Kashani · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Farhad Ravandi-Kashani
[email protected]
713-792-7305
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Efficacy of rituximab on achievement of complete response after therapy with cladribineAt 12 weeks

    Defined as the absence of hairy cells in the bone marrow or the presence of less than 1 percent atypical cells and the disappearance of all evidence of hairy cell leukemia on physical examination. Monitored using the method of Thall, Simon, Estey as extended by Thall and Sung.

  • Monitoring the related toxicity for the therapy Grade 3-4Up to 1 year

    Monitored using the method of Thall, Simon, Estey as extended by Thall and Sung.

  • Efficacy of rituximab in eradication of minimal residual disease after cladribine therapy, assessed by immunophenotyping of bone marrow and peripheral bloodUp to 4 weeks after the last dose of rituximab

    The method of Thall, Simon, Estey as extended by Thall and Sung will be used for efficacy and safety monitoring.

  • Efficacy of rituximab on prolongation of event-free survivalUp to 1 year
  • Efficacy of rituximab on prolongation of overall survivalUp to 1 year