OncoMatch/Clinical Trials/NCT06854003
BRAZAN: A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed by Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance in Treatment-Naïve Mantle Cell Lymphoma
Is NCT06854003 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for mantle cell lymphoma.
Treatment: Bendamustine · Rituximab · Cytarabine · Zanubrutinib · Sonrotoclax — This study aims to evaluate the efficacy and safety of an induction regimen combining Bendamustine, Rituximab, Cytarabine (AraC), and Zanubrutinib (BRAZAN), followed by maintenance therapy with Zanubrutinib and Rituximab with or without Sonrotoclax in participants with Mantle Cell Lymphoma (MCL). The names of the study drugs involved in this study are: * bendamustine (a type of alkylating agent) * rituximab (a type of monoclonal antibody) * cytarabine (a type of antineoplastic) * zanubrutinib (a type of kinase inhibitor) * sonrotoclax (a type of BCL2 inhibitor)
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: TP53 status assessed
TP53 status should be assessed (preferably by next-generation sequencing; immunohistochemical staining would be next-preferred).
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-lymphoma therapy
Exception: Prior radiotherapy for localized disease is permitted. A course of radiotherapy for urgent symptomatic disease is also permitted. Short-course systemic corticosteroids is permissible for disease control (must be < 7 days and ≤ 100mg/day of prednisone or ≤ 20mg/day of dexamethasone, or equivalent). Steroids must be discontinued prior to study treatment.
No prior anti-lymphoma therapy, with the following exceptions: Prior radiotherapy for localized disease is permitted. A course of radiotherapy for urgent symptomatic disease is also permitted. Short-course systemic corticosteroids is permissible for disease control (must be < 7 days and ≤ 100mg/day of prednisone or ≤ 20mg/day of dexamethasone, or equivalent). Steroids must be discontinued prior to study treatment.
Lab requirements
Blood counts
Absolute neutrophil count 1.0 x109/L, or 0.5 x109/L if bone marrow involvement (use of growth factor support allowed). Hemoglobin 8 g/dL and independent of transfusion within 7 days of screening. Platelets 100 x109/L, or 50 x109/L if bone marrow involvement, and independent of transfusion within 7 days of screening.
Kidney function
Estimated CrCl 30mL/min (by Cockcroft-Gault formula or by 24-hour urine collection).
Liver function
AST/ALT < 2.5 X institutional upper limit of normal (ULN), or < 5.0 X institutional ULN if documented liver involvement of lymphoma. Total bilirubin < 2.0 X ULN (unless active hemolysis); for subjects with Gilbert's Syndrome, direct bilirubin < 1.5 X ULN.
Cardiac function
No New York Heart Association Class III or IV heart failure. No myocardial infarction within 6 months of screening. No unstable angina within 3 months prior to screening. No active uncontrolled arrhythmia. No history of clinically significant ventricular arrhythmias within 6 months of screening (eg sustained Vtach, Vfib, torsades de pointes). No history of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place. No uncontrolled hypertension as indicated by 2 consecutive blood pressure measurements showing systolic blood pressure > 170 mm Hg and diastolic blood pressure > 105 mm Hg at screening. Screening 12-lead EKG showing a baseline QTcF (Fridericia's correction) > 480 msec.
Adequate hematologic and organ function defined as: Absolute neutrophil count 1.0 x109/L, or 0.5 x109/L if bone marrow involvement (use of growth factor support allowed). Hemoglobin 8 g/dL and independent of transfusion within 7 days of screening. Platelets 100 x109/L, or 50 x109/L if bone marrow involvement, and independent of transfusion within 7 days of screening. Estimated CrCl 30mL/min (by Cockcroft-Gault formula or by 24-hour urine collection). AST/ALT < 2.5 X institutional upper limit of normal (ULN), or < 5.0 X institutional ULN if documented liver involvement of lymphoma. Total bilirubin < 2.0 X ULN (unless active hemolysis); for subjects with Gilbert's Syndrome, direct bilirubin < 1.5 X ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Arizona · Phoenix, Arizona
- Beth Israel Deaconess Medical Center · Boston, Massachusetts
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
- Mayo Clinic · Rochester, Minnesota
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