Zanubrutinib and Tafasitamab for Mantle Cell Lymphoma
This study is looking at a combination of two drugs, Zanubrutinib and Tafasitamab, for people with Mantle Cell Lymphoma (a type of cancer that starts in white blood cells). The main goal is to find the best dose of Zanubrutinib to use with Tafasitamab. It will also check how well this combination treatment works. You might be able to join if you are 18 or older and have a confirmed diagnosis of Mantle Cell Lymphoma. The study aims to enroll 27 participants. The researchers will look for how many people have a complete response (meaning the cancer is no longer detectable) to the treatment.
- Study design
- This interventional study plans to enroll 27 participants. It will first determine the best dose of Zanubrutinib and then assess the effectiveness of the combination treatment.
- What's involved
- Participants will take Zanubrutinib capsules by mouth daily and receive Tafasitamab intravenously (through a vein) on specific days during 28-day cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess the complete response rate to Zanubrutinib for up to 48 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma
At a glance
Conditions
NCT06029309
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Miami
Miami, Floridastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Alvaro Alencar, MD · PRINCIPAL_INVESTIGATOR · University of Miami
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Phase 1: Recommended Phase 2 Dose (RP2D) of Zanubrutinib4 weeks
Determination of the RP2D of Zanubrutinib, when used in combination with Tafasitamab, based on evaluation of dose limiting toxicity (DLT) in participants during the Phase 1 part of the study. DLT will be defined as the occurrence of specified adverse events (AEs) at least possibly related to the study therapy during the DLT review period.
- Phase 2: Rate of Complete Response (CR) to Zanubrutinib at RP2DUp to 48 weeks
The complete response (CR) rate among study participants in Phase 2 to Zanubrutinib at the RP2D in combination with Tafasitamab will be assessed. Response will be assessed using positron emission tomography (PET)/computerized tomography (CT) according to the Lugano 2014 criteria. CR will be defined by a Deauville score of less than or equal to (≤) 3.