NCT06846463 Zanubrutinib in Patients With DLBCL and MYD88 or NOTCH1 Mutation or CD5+
| NCT ID | NCT06846463 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Virginia Commonwealth University |
| Condition | Diffuse Large B-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2025-05-27 |
| Primary Completion | 2029-07-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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
Inclusion Criteria: * 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. * Patient must have received no more than one cycle of R-CHOP prior to enrollment. Length of time between first R-CHOP treatment and planned 2nd R-CHOP treatment should vary by no more than 21 days ± 3 days. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. * Adequate bone marrow function as defined by: * Absolute neutrophil count (ANC) ≥1000/mm3, except for patients with bone marrow involvement in which ANC must be ≥500/mm3. * Platelet ≥75,000/mm3, except for patients with bone marrow involvement in which the platelet count must be ≥30,000/mm3. * Hemoglobin ≥7 g/dL, after transfusion if necessary * Adequ