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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

NCT07257510•Peking University Third Hospital

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Pathologically confirmed mantle cell lymphoma
•Age 18-80 years, both genders are eligible..
•Untreated MCL.
•At least one measurable lesion. Measurable disease is defined as a tumor mass measurable in one or two dimensions ≥1.5 cm, as well as measurable spleen lesions.
•Any one of the following factors is present:: MIPI intermediate-high risk, ki67≥30%, blastoid/pleomorphic, TP53 abnormality (mutation/deletion) or p53 protein expression \>50%, large mass (maximum diameter ≥7.5cm), complex karyotype (≥3 chromosomal abnormalities (excluding t(11; 14)))
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
•Hematologic function is adequate, defined as:
•1. Absolute neutrophil count (ANC) ≥1×109/L, growth factor support must not be used within 7 days prior to testing;
•2. Platelet count ≥75×10⁹/L, or ≥50×10⁹/L (if bone marrow involvement), no use of growth factor support or transfusion allowed within 7 days prior to testing.
•Adequate hepatic function per local laboratory reference range as follow:
+9 more criteria

Exclusion Criteria

•Current central nervous system involvement or suspected patients and those with a history of this condition
•Previously received systemic treatment for MCL, including BTKi.
•Uncontrolled active systemic fungal, bacterial, or viral infections (defined as persistent signs/symptoms related to the infection despite the use of appropriate antibiotics, antiviral therapy, and/or other treatments with no improvement).
•Known human immunodeficiency virus (HIV) infection, or the following serological status indicating active hepatitis B or C virus infection:
•1. Subjects with positive hepatitis B virus core antibody (HBcAb) and negative surface antigen (HBsAg) must have a negative polymerase chain reaction (PCR) result prior to the first dose. Subjects with positive HBsAg or HBV-DNA:
•2. Subjects with positive hepatitis C antibodies must have an HCV-RNA negative result before the first dose. Subjects with positive hepatitis C PCR results will not be eligible for this study.
•Clinically severe cardiovascular diseases, including:
•1. Myocardial infarction occurring within the 6 months prior to screening;
•2. Unstable angina occurring within 3 months prior to screening;
•3. Clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes ventricular tachycardia);
+13 more criteria

Locations (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

August 1, 2025

Primary Completion Date

August 1, 2028

Completion Date

August 1, 2028

Last Updated

December 2, 2025

Enrollment

ESTIMATED participants

Conditions

Mantle Cell Lymphoma (MCL)POZ

Interventions

Pomalidomide

DRUG

Orelabrutinib

DRUG

Zuberitamab

DRUG

Zuberitamab

DRUG

Contacts

Hongmei Jing

CONTACT

86 010-82266781 hongmei_jing@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell Lymphoma

Inclusion Criteria

Exclusion Criteria

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