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

NCT07690761 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-07-08

No results posted yet for this study

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.

Conditions

  • Hairy Cell Leukemia
  • Hairy Cell Leukemia Variant

Interventions

DRUG

Zanubrutinib

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.

Sponsors & Collaborators

  • Meir Medical Center

    collaborator OTHER

  • Hadassah Medical Organization

    collaborator OTHER

  • Bnai Zion Medical Center

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-12-31
Completion
2033-12-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07690761 on ClinicalTrials.gov