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OncoMatch/Clinical Trials/NCT06029309

Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma

Is NCT06029309 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Zanubrutinib and Tafasitamab for mantle cell lymphoma.

Phase 1/2RecruitingAlvaro Alencar, MDNCT06029309Data as of May 2026

Treatment: Zanubrutinib · TafasitamabThe main purpose of this study to find the ideal dose for the combination treatment of Zanubrutinib and Tafasitamab in patients with mantle cell lymphoma. Another purpose is to assess how well the combination treatment works in patients with the study disease.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: investigational agent

Patients receiving any other investigational agents

Cannot have received: allogenic hematopoietic stem cell transplantation

History of allogenic hematopoietic stem cell transplantation prior to enrollment

Cannot have received: corticosteroids

Exception: ≤ prednisone 10 mg/day or its equivalent with antineoplastic intent within 7 days of the start of study drug

Prior corticosteroids in excess of prednisone 10 mg/day or its equivalent with antineoplastic intent within 7 days of the start of study drug

Cannot have received: chemotherapy

Exception: within 3 weeks of the start of study drug

Prior chemotherapy, targeted therapy, or radiation therapy within 3 weeks

Cannot have received: targeted therapy

Exception: within 3 weeks of the start of study drug

Prior chemotherapy, targeted therapy, or radiation therapy within 3 weeks

Cannot have received: radiation therapy

Exception: within 3 weeks of the start of study drug

Prior chemotherapy, targeted therapy, or radiation therapy within 3 weeks

Cannot have received: antineoplastic therapy with Chinese herbal medication

Exception: within 4 weeks of the start of study drug

antineoplastic therapy with Chinese herbal medication or antibody-based therapies within 4 weeks of the start of study drug

Cannot have received: antibody-based therapies

Exception: within 4 weeks of the start of study drug

antineoplastic therapy with Chinese herbal medication or antibody-based therapies within 4 weeks of the start of study drug

Cannot have received: live vaccine

Exception: within 28 days prior to start of study treatment

Administration of live vaccine within 28 days prior to start of study treatment

Lab requirements

Blood counts

Absolute neutrophil count >1,000/mm3 independent of growth factor support within 7 days of study entry (>700/mm3 if lymphoma involvement of the bone marrow or spleen); Platelets >70,000/mm3 independent of transfusion support within 7 days of study entry (>50,000/mm3 if lymphoma involvement of the bone marrow or spleen); Hemoglobin >9 g/dL or >8 g/dL in case of bone marrow involvement by lymphoma independent of transfusion support within 7 days of study entry

Kidney function

Creatinine within normal institutional limits, or creatinine clearance ≥ 40 mL/min (creatinine clearance ≥ 30 mL/min if due to lymphoma)

Liver function

Total bilirubin < 1.5 x within normal institutional limits (unless known history of Gilbert's disease or up to 3 x ULN if due to lymphoma involvement of liver); GGT/AST/ALT ≤ 2.5 x institutional upper limit of normal

Cardiac function

QTcF ≤ 450 msec; no significant ECG abnormalities including second-degree atrioventricular block Type II, or third-degree atrioventricular block

Patients must have normal organ and marrow function as defined below: ... QT interval corrected with Fridericia's formula (QTcF) > 450 msec or other significant ECG abnormalities including second-degree atrioventricular block Type II, or third-degree atrioventricular block

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Miami · Miami, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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