Actively Recruiting
Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell Lymphoma
Led by Peking University Third Hospital · Updated on 2025-12-02
34
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed mantle cell lymphoma
- Age between 18 and 80 years, all genders eligible
- Untreated mantle cell lymphoma
- At least one measurable lesion of 1.5 cm or larger, including spleen lesions
- Presence of at least one high-risk factor such as intermediate-high MIPI score, ki67 ≥30%, blastoid/pleomorphic features, TP53 abnormality, large tumor mass (≥7.5 cm), or complex karyotype
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate blood function: absolute neutrophil count ≥1×10⁹/L; platelet count ≥75×10⁹/L or ≥50×10⁹/L if bone marrow involved
- Adequate liver function with AST and ALT ≤2.5 times upper limit of normal and bilirubin ≤2 times upper limit (up to 5 times if Gilbert's syndrome)
- Adequate kidney function with creatinine clearance ≥60 mL/min and serum creatinine ≤1.5 times upper limit
- International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤1.5 times upper limit
- Life expectancy longer than 3 months
- Ability to provide informed consent and comply with study requirements
- Ability to follow study visit schedule and protocol requirements
You will not qualify if you...
- Current or suspected central nervous system involvement
- Previous systemic treatment for mantle cell lymphoma, including BTKi
- Uncontrolled active fungal, bacterial, or viral infections
- Known HIV infection or active hepatitis B or C infection
- Severe cardiovascular diseases including recent myocardial infarction, unstable angina, serious arrhythmias, prolonged QTc, high-grade AV block, or severe heart failure
- History of severe bleeding disorders or recent deep vein thrombosis or pulmonary embolism
- Recent significant cerebrovascular events such as stroke or intracranial hemorrhage
- Inability to swallow capsules or significant gastrointestinal disorders
- Continuous use or recent use of strong or moderate CYP3A inhibitors or inducers
- Use of warfarin or equivalent anticoagulants within 7 days after first dose
- Pregnancy or breastfeeding
- Hypersensitivity to any study drug
- Mental or cognitive impairments affecting consent or compliance
- History of drug abuse or alcoholism
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
H
Hongmei Jing
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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