Hairy Cell LeukemiaPhase 2Rituximab+ ZanNCT07690761
Rituximab+ Zanubrutinib for Patients With Hairy Cell Leukemia and Hairy Cell Variant
A Phase 2 study testing Zanubrutinib in people with Hairy Cell Leukemia and Hairy Cell Leukemia Variant, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hairy Cell Leukemia, Hairy Cell Leukemia Variant
- What is being tested?
- Zanubrutinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2026to 31 Dec 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter Phase 2 Study of Rituximab+ Zanubrutinib for Patients With Hairy Cell Leukemia and Hairy Cell Variant (RiZan Regimen)
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.
Read the detailed description
Patients will receive Zanubrutinib orally (PO) ) 160 mg twice daily OR 320 mg once daily on days 1-28. (However, if participants preference is 320 mg once a day, it is recommended that participants continues to use the same dosing schedule throughout the treatment cycles to support better treatment adherence (ie., recommend patients to take the medication at approximately the same time each day). This dosing preference will be recorded in the eCRF." ) Cycles will repeat every 28 days up to lack of response to therapy, or continually at per physician discretion in the absence of disease progression or unacceptable toxicity.
IV rituximab will be administrated every 7 days starting from day 1, for a total of 8 doses. Dose of rituximab will be 375 mg/M2.
After completion of study treatment, patients will be followed up every 3 months for a total of 60 months.
- Conditions
- Hairy Cell Leukemia, Hairy Cell Leukemia Variant
- Being tested
- Zanubrutinib
- Medical subject headings
- Leukemia, Hairy Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
Patients will receive Zanubrutinib orally (PO) ) 160 mg twice daily OR 320 mg once daily on days 1-28. (However, if patients' preference is 320 mg once a day, it is recommended that he/she continues to use the same dosing schedule throughout the treatment cycles to support better treatment adherence (ie., recommend patients to take the medication at approximately the same time each day). This dosing preference will be recorded in the eCRF." ) Cycles will repeat every 28 days up to lack of response to therapy, or continually at per physician discretion in the absence of disease progression or unacceptable toxicity.
IV rituximab will be administrated every 7 days starting from day 1, for a total of 8 doses. Dose of rituximab will be 375 mg/M2.
After completion of study treatment, patients will be followed up every 3 months for a total of 60 months.
| Study group | Role | What they receive |
|---|---|---|
| ZANUBRUTINIB+ RITUXIMAB | Experimental | Not described Receives: Drug: Zanubrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR
- To determine the overall response rate (complete response [CR] and partial response [PR]) of hairy cell leukemia (HCL) at 32, week after beginning therapy with Rituximab+ Zanubrutinib (in comparison to ibrutinib study)
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Jun 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hairy Cell LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Collaborators
- Meir Medical Center, Hadassah Medical Organization
- Responsible party
- Principal investigator, tamar.tadmor, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690761
- Sponsor's protocol ID
- IIT-CL-BGB3111-0088
- Acronym
- Rituximab+ Zan
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase 2 Study of Rituximab+ Zanubrutinib for Patients With Hairy Cell Leukemia and Hairy Cell Variant (RiZan Regimen)
- ClinicalTrials.gov ID
- NCT07690761
- Acronym / sponsor ID
- Rituximab+ Zan / IIT-CL-BGB3111-0088
- Conditions
- Hairy Cell Leukemia, Hairy Cell Leukemia Variant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Collaborators
- Meir Medical Center, Hadassah Medical Organization
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will receive Zanubrutinib orally (PO) ) 160 mg twice daily OR 320 mg once daily on days 1-28. (However, if participants preference is 320 mg once a day, it is recommended that participants continues to use the same dosing schedule throughout the treatment cycles to support better treatment adherence (ie., recommend patients to take the medication at approximately the same time each day). This dosing preference will be recorded in the eCRF." ) Cycles will repeat every 28 days up to lack of response to therapy, or continually at per physician discretion in the absence of disease progression or unacceptable toxicity.
IV rituximab will be administrated every 7 days starting from day 1, for a total of 8 doses. Dose of rituximab will be 375 mg/M2.
After completion of study treatment, patients will be followed up every 3 months for a total of 60 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZANUBRUTINIB+ RITUXIMAB | Experimental | Drug: Zanubrutinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanubrutinibPatients will receive Zanubrutinib orally (PO) ) 160 mg twice daily OR 320 mg once daily on days 1-28. (However, if patients' preference is 320 mg once a day, it is recommended that he/she continues to use the same dosing schedule throughout the treatment cycles to support better treatment adherence (ie., recommend patients to take the medication at approximately the same time each day). This dosing preference will be recorded in the eCRF." ) Cycles will repeat every 28 days up to lack of response to therapy, or continually at per physician discretion in the absence of disease progression or unacceptable toxicity. IV rituximab will be administrated every 7 days starting from day 1, for a total of 8 doses. Dose of rituximab will be 375 mg/M2. After completion of study treatment, patients will be followed up every 3 months for a total of 60 months. | Drug | ZANUBRUTINIB+ RITUXIMAB |
Primary outcome
CR
Time frame: 32 weeks
• To determine the overall response rate (complete response [CR] and partial response [PR]) of hairy cell leukemia (HCL) at 32, week after beginning therapy with Rituximab+ Zanubrutinib (in comparison to ibrutinib study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanubrutinib in people with Hairy Cell Leukemia and Hairy Cell Leukemia Variant, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR (time frame: 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.