Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma

Recruiting now · Phase 1/Phase 2

Conditions studied: Mantle Cell Lymphoma

In brief

The 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.

Key facts

Study ID: NCT06029309
Run by: Alvaro Alencar, MD
People needed: 27
Starts: 2024-05-03
Expected to finish: 2032-05-01
Last updated by the study team: 2025-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Men and women ≥ 18 years of age
Patients must have histologic confirmation of mantle cell lymphoma (MCL) defined by the World Health Organization (WHO) classification
Baseline PET/CT scans must demonstrate fluorodeoxyglucose (FDG) avid lesions compatible with CT defined anatomical tumor sites. Patients should have at least one measurable site of disease per Lugano classification
Patient should have indication according to primary investigator for treatment initiation
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Life expectancy of greater than 4 months.
Willingness to avoid pregnancy or fathering children during the study and for at least 90 days after the last dose of the study drug.
Patients must have normal organ and marrow function as defined below:
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 independent of transfusion support within 7 days of study entry 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.
Total bilirubin < 1.5 x within normal institutional limits (unless known history of Gilbert's disease or up to 3 x upper limit of normal (ULN) if due to lymphoma involvement of liver)
Gamma-Glutamyl Transpeptidase (GGT)/Aspartate transaminase (AST, SGOT)/Alanine transaminase (ALT, SGPT) ≤ 2.5 x institutional upper limit of normal
Creatinine within normal institutional limits, or creatinine clearance ≥ 40 mL/min (as estimated by the Cockcroft-Gault equation) for patients with creatinine levels above institutional normal (creatinine clearance ≥ 30 mL/min as estimated by the Cockcroft-Gault equation if due to lymphoma).
Inclusion Criteria, Phase 1 Only:
Relapsed MCL patients with at least 1 but no more than 3 lines of therapy, regardless of previous Bruton Tyrosine Kinase (BTK) inhibitor exposure
Inclusion Criteria, Phase 2 Only:
Untreated symptomatic MCL deemed by the primary investigator not to be eligible for intensive combination immunochemotherapy.
Exclusion Criteria, Phase 1 and 2:
Patients receiving any other investigational agents
Patients with known central nervous system involvement of lymphoma
Uncontrolled intercurrent illness such as: clinically significant active cardiovascular disease such as uncontrolled or symptomatic arrhythmia, uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) Class III-IV, history of myocardial infarction within 6 months of screening, stroke in last 6 months, liver cirrhosis, autoimmune disorder requiring immunosuppression or long-term corticosteroids (>10 mg daily prednisone equivalent), or any other serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
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
Prior or concurrent malignancies with exception of surgically cured carcinoma in situ (CIS) of the uterus, carcinoma of the skin without evidence of disease for ≥5 years
Concurrent malignancy requiring active therapy

Where it is running

University of Miami — Miami, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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