Actively Recruiting
Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma
Led by Alvaro Alencar, MD · Updated on 2025-10-06
27
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
Sponsors
A
Alvaro Alencar, MD
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age or older
- Histologic confirmation of mantle cell lymphoma according to WHO classification
- Baseline PET/CT scans showing FDG avid lesions with at least one measurable site of disease per Lugano classification
- Indication for treatment initiation as determined by the primary investigator
- ECOG performance status of 2 or less
- Life expectancy greater than 4 months
- Willing to avoid pregnancy or fathering children during the study and for at least 90 days after last dose
- Normal organ and marrow function based on specified blood counts and liver and kidney tests
- Phase 1 only: Relapsed mantle cell lymphoma patients with 1 to 3 prior therapies, regardless of previous BTK inhibitor exposure
- Phase 2 only: Untreated symptomatic mantle cell lymphoma patients not eligible for intensive combination immunochemotherapy
You will not qualify if you...
- Receiving any other investigational agents
- Known central nervous system involvement of lymphoma
- Uncontrolled active cardiovascular disease or other serious medical conditions or psychiatric illness preventing informed consent
- QTcF interval greater than 450 msec or significant ECG abnormalities
- Prior or concurrent malignancies except certain surgically cured carcinomas
- Concurrent malignancy requiring active therapy
- Known HIV infection requiring antiviral therapy
- Pregnant or breastfeeding women
- Active hepatitis B or C infection not controlled by PCR criteria
- Ongoing treatment with certain CYP3A inhibitors or inducers without safe substitution
- History of allogenic hematopoietic stem cell transplantation
- Active systemic infections including SARS-CoV-2 or infections requiring antimicrobial therapy
- Live vaccine administration within 28 days before study treatment
- Life-threatening illness or organ dysfunction compromising safety
- Toxicity from prior chemotherapy not recovered to Grade 1 except specified counts
- Unable to swallow capsules or significant gastrointestinal dysfunction
- Recent corticosteroids, chemotherapy, targeted therapy, radiation, or antibody-based therapies within specified time frames
- History of severe bleeding disorders or recent stroke or intracranial hemorrhage
- Major surgery within 4 weeks before study drug
- Need for treatment with warfarin or vitamin K antagonists
- Contraindications per Tafasitamab US Prescribing Information
- Impaired decision-making capacity
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
A
Alvaro Alencar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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