Zanubrutinib in Patients With DLBCL and MYD88 or NOTCH1 Mutation or CD5+
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University
About this trial
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).
Eligibility criteria
Qualifiers
Patients must have a documented pathologic diagnosis of DLBCL at any stage.
Must have documented MYD88 L265P, CD79B, or NOTCH1 truncation mutation or be CD5+ by IHC.
Age ≥18 years on the day of signing the informed consent form.
Patients must have measurable disease on Positron Emission Tomography-Computed Tomography scan (CT/PET) imaging.
Disqualifiers
Patients with high grade B-cell lymphoma with myelocytomatosis oncogene /immunoglobulin heavy-chain (MYC)/IGH and BCL-2 rearrangements.
Patients with brain metastasis.
Patients with peripheral neuropathy CTCAE grade ≥2.
Myocardial infarction within 6 months before screening.
Trial design
Treatments tested in this trial
- Zanubrutinib
Treatment groups
21 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov