Rituximab+ Zanubrutinib for Patients With Hairy Cell Leukemia and Hairy Cell Variant

Enrolling by invitation · Phase 2

Conditions studied: Hairy Cell Leukemia, Hairy Cell Leukemia Variant

In brief

investigators propose a phase II, open label-nonrandomized, single arm, multicenter study aiming to assess the safety and efficacy with the combination of Rituximab and Zanubrutinib in patients with HAIRY CELL LUKEMIA HCL, or HAIRY CELL LEUKEMIA VARIANT-HCLv.

Key facts

Study ID

NCT07690761

Run by

Bnai Zion Medical Center

People needed

12

Starts

2026-06-01

Expected to finish

2033-12-31

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor
• Zanubrutinib is extensively metabolized by CYP3A4/5; patients who received a strong cytochrome P450 (CYP) 3A inhibitor within 7 days prior to the first dose of Zanubrutinib or patients who require continuous treatment with a strong CYP3A inhibitor; therefore, any medications or substances that are strong inhibitors of CYP3A4/5 should be discontinued if possible; Zanubrutinib dose modification to 80 mg QD is recommended when patients are on strong CYP3A inhibitors; because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list; medical reference texts such as the Physicians' Desk Reference may also provide this information; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; recent infections requiring systemic treatment need to have completed therapy > 14 days before the first dose of study drug
• Pregnant or breast-feeding or intending to become pregnant during the study
• Have had chemotherapy (including purine analogs), rituximab, and other investigational agents within four weeks prior to entering the study.
• Invasive malignancy within the past 2 years prior to first study drug administration, except for adequately treated (with curative intent) basal or squamous cell carcinoma, melanoma, in situ carcinoma of the cervix, in situ ductal adenocarcinoma of the breast, in situ prostate cancer, or limited stage bladder cancer or other cancers from which the patient has been disease-free for at least 2 years
• Active HIV, hepatitis B and hepatitis C or any clinically significant history of liver disease. Hepatitis B prior infection is not a contraindication though will require therapy.
• Known hypersensitivity to any of the study drugs
• Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia
• Patient is unable to swallow capsules, or has disease significantly affecting gastrointestinal function or resection of the stomach or small bowel, or symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction
• History of intracranial hemorrhage within 6 months prior to enrollment

Where it is running

• Bnai Zion — Haifa, Israel

Full record on ClinicalTrials.gov

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