OncoMatch/Clinical Trials/NCT06846463
Zanubrutinib in Patients With DLBCL and MYD88 or NOTCH1 Mutation or CD5+
Is NCT06846463 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Zanubrutinib for diffuse large b-cell lymphoma.
Treatment: Zanubrutinib — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: MYD88 L265P
documented MYD88 L265P
Required: CD79B mutation
documented...CD79B
Required: NOTCH1 truncation mutation
documented...NOTCH1 truncation mutation
Required: CD5 overexpression (CD5+ by IHC)
CD5+ by IHC
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
ANC ≥1000/mm3 (≥500/mm3 if bone marrow involvement); Platelet ≥75,000/mm3 (≥30,000/mm3 if bone marrow involvement); Hemoglobin ≥7 g/dL (after transfusion if necessary)
Kidney function
Creatinine clearance ≥30 mL/min (Cockcroft-Gault equation)
Liver function
AST/ALT ≤2.5 × ULN; serum total bilirubin ≤3 x ULN (except patients with Gilberts syndrome 3g/dl)
Cardiac function
Left ventricular ejection fraction (LVEF) ≥55% on screening echocardiogram
Adequate bone marrow function as defined by: 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. Adequate organ function defined as: Creatinine clearance ≥30 mL/min as estimated by the Cockcroft-Gault equation. AST/ALT ≤2.5 × ULN. Serum total bilirubin ≤3 x ULN (except patients with Gilberts syndrome 3g/dl). Left ventricular ejection fraction (LVEF) <55% on screening echocardiogram [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Virginia Commonwealth University · Richmond, Virginia
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