Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06846463

Zanubrutinib in Patients With DLBCL and MYD88 or NOTCH1 Mutation or CD5+

Led by Virginia Commonwealth University · Updated on 2026-01-23

21

Participants Needed

1

Research Sites

374 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is a single-arm, open label, non-randomized, phase 2 trial of zanubrutinib in patients with diffuse large B-cell lymphoma (DLBCL) who have an MYD88 L265P mutation, a CD79B mutation, a NOTCH1 truncation, or who are CD5+ by immunohistochemistry (IHC).

CONDITIONS

Official Title

Zanubrutinib in Patients With DLBCL and MYD88 or NOTCH1 Mutation or CD5+

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have a documented diagnosis of diffuse large B-cell lymphoma (DLBCL) at any stage.
  • Must have documented MYD88 L265P, CD79B, or NOTCH1 truncation mutation or be CD5 positive by immunohistochemistry.
  • Age 18 years or older at the time of signing informed consent.
  • Must have measurable disease confirmed by PET-CT imaging.
  • Must have received no more than one cycle of R-CHOP chemotherapy before enrollment.
  • Time between first and second R-CHOP treatment should be within 21 days plus or minus 3 days.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Adequate bone marrow function: absolute neutrophil count (ANC) at least 1000/mm3 (or 500/mm3 if bone marrow involvement), platelet count at least 75,000/mm3 (or 30,000/mm3 if bone marrow involvement), and hemoglobin at least 7 g/dL after transfusion if needed.
  • Adequate organ function including creatinine clearance of at least 30 mL/min, liver enzymes no more than 2.5 times the upper limit of normal, and total bilirubin no more than 3 times the upper limit of normal (except Gilbert's syndrome).
  • Women of childbearing potential must have a negative pregnancy test within 7 days before treatment.
  • Women of childbearing potential and men must agree to use highly effective birth control during treatment and for 1 month after treatment for women and 1 week for men.
  • No known allergies or intolerance to corticosteroids or monoclonal antibodies.
  • Able to provide informed consent and comply with study requirements.
Not Eligible

You will not qualify if you...

  • Patients with high-grade B-cell lymphoma with MYC/IGH and BCL-2 rearrangements.
  • Patients with brain metastasis.
  • Patients with peripheral neuropathy grade 2 or higher.
  • Uncontrolled or significant cardiovascular disease, including recent heart attack, unstable angina, severe heart failure, or serious arrhythmias.
  • History of other cancers within the past 3 years except certain treated skin, bladder, cervical, breast, or prostate cancers.
  • History of severe bleeding disorders or spontaneous bleeding requiring medical intervention.
  • History of stroke or brain bleeding within 6 months before study drug.
  • Severe lung disease as judged by the investigator.
  • Inability to swallow capsules or serious gastrointestinal problems.
  • Active infections requiring systemic treatment.
  • Medical conditions making study drug use unsafe or affecting interpretation of side effects.
  • Active HIV infection or active hepatitis B or C infection unless virus is undetectable and monitoring agreed.
  • Major surgery within 4 weeks before first study drug dose.
  • Pregnant or breastfeeding women.
  • Left ventricular ejection fraction less than 55%.
  • Recent or planned vaccination with live vaccine within 28 days before or during study treatment.
  • Allergic to zanubrutinib, rituximab, cyclophosphamide, doxorubicin, vincristine, or prednisone.
  • Requires treatment with strong CYP3A inducers.
  • Participation in another therapeutic clinical trial.
  • Active autoimmune anemia or thrombocytopenia.
  • Requires ongoing treatment with warfarin or derivatives.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Actively Recruiting

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Research Team

M

Massey IIT Research Operations

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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