Combining cladribine and rituximab to treat hairy cell leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effectiveness and side effects of cladribine and rituximab in treating patients with hairy cell leukemia, including those with recurrent disease. The study involves administering cladribine intravenously for five days, followed by rituximab weekly for eight weeks. The primary objectives include assessing the complete response rate, the eradication of minimal residual disease, and the long-term disease-free and overall survival rates. Additionally, the trial aims to identify potential predictors of treatment outcomes through molecular evaluations.

Why it matters

Who can join: the full rules

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)

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Farhad Ravandi-Kashani — M.D. Anderson Cancer Center
• Study coordinator: Farhad Ravandi-Kashani
• Email: fravandi@mdanderson.org
• Phone: 713-792-7305

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This trial tests whether combining tovorafenib and rituximab is safe and effective for adults with relapsed or refractory classical hairy cell leukemia and compares that combination to cladribine plus rituximab in newly diagnosed patients.

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• Comparing two treatment combinations for Hairy Cell Leukemia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.