RecruitingNot ApplicableNCT07257510

Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell Lymphoma

A Prospective, Multicenter Clinical Study of Pomalidomide Combined With Orelabrutinib and Zuberitamab in Treatment-Naive Mantle Cell Lymphoma


Sponsor

Peking University Third Hospital

Enrollment

34 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This multicenter trial evaluates the efficacy and safety of pomalidomide combined with orelabrutinib and zuberitamab (POZ) in patients with mantle cell lymphoma (MCL). After six cycles of POZ, patients who achieved minimal residual disease (MRD) negativity received maintenance therapy with orelabrutinib plus zuberitamab for up to 18 cycles. Those with MRD positivity were excluded and received alternative treatments. The primary endpoint is the MRD rate after six cycles of POZ. Secondary endpoints include progression-free survival (PFS), overall survival (OS), MRD rate, objective response rate (ORR), and safety.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug combination — pomalidomide, orelabrutinib, and zuberitamab — as a first-line treatment for mantle cell lymphoma (MCL), a type of blood cancer that typically affects older adults. **You may be eligible if...** - You are 18 to 80 years old - You have a confirmed diagnosis of mantle cell lymphoma - You have not received any prior treatment for MCL - You have at least one measurable tumor site **You may NOT be eligible if...** - You have previously been treated for MCL - You have cancer that has spread to the brain - You have significant liver, kidney, or bone marrow problems - You have active serious infections or other cancers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPomalidomide

4mg/day PO once daily, day1-21/cycle

DRUGOrelabrutinib

150mg/day PO once daily

DRUGZuberitamab

375 mg/m² IV on day 1/cycle

DRUGZuberitamab

375 mg/m² IV on day 1 of cycle 7, 10, 13, 16, 19 and 22,


Locations(1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

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NCT07257510


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