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Mantle Cell Lymphoma (MCL)NCT07257510

Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell Lymphoma

A study testing Pomalidomide, Orelabrutinib and Zuberitamab in people with Mantle Cell Lymphoma (MCL) and POZ, run by Peking University Third Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Mantle Cell Lymphoma (MCL), POZ
What is being tested?
Pomalidomide, Orelabrutinib and Zuberitamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteChina
Study dates
1 Aug 2025to 1 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Hematologic function is adequate, defined as:
  • Absolute neutrophil count (ANC) ≥1×109/L, growth factor support must not be used within 7 days prior to testing;
  • 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:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× the upper limit of normal (ULN);
  • Bilirubin ≤ 2 × ULN (except for those diagnosed with Gilbert's syndrome, which allows up to 5 × ULN)
  • Adequate renal function as demonstrated by:
  • Creatinine clearance ≥60 mL/min (estimated using the Cockcroft-Gault formula or the glomerular filtration rate [eGFR] estimated using the Modification of Diet in Renal Disease [MDRD] formula)
  • Serum creatinine ≤1.5×ULN
  • International Normalized Ratio (INR) ≤ 1.5 × ULN and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN
  • Life expectancy of more than 3 months.
  • Ability to provide written informed consent and understand and comply with study requirements.
  • Able to comply with the study visit schedule and other protocol requirements

Who cannot join

  • 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:
  • 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:
  • 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.
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  • Clinically severe cardiovascular diseases, including:
  • Myocardial infarction occurring within the 6 months prior to screening;
  • Unstable angina occurring within 3 months prior to screening;
  • Clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes ventricular tachycardia);
  • QTcF (corrected by Fridericia's formula) > 480 msec;
  • History of second-degree type II atrioventricular (AV) conduction block or third-degree atrioventricular conduction block;
  • III or IV congestive heart failure as defined by the New York Heart Association (NYHA)
  • History of severe hemorrhagic disorders, such as hemophilia A, hemophilia B, von Willebrand disease, or a history of spontaneous bleeding requiring blood transfusion or other medical interventions.
  • History of deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past 12 months
  • History of significant cerebrovascular disease/events within 6 months prior to the first administration of the investigational drug, including stroke or intracranial hemorrhage.
  • Unable to swallow capsules or having significant gastrointestinal functional disorders, such as malabsorption syndrome, gastric or small intestine resection, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction.
  • Continuous treatment with strong and moderate CYP3A inhibitors or CYP3A inducers is required. If the patient has taken strong or moderate CYP3A inhibitors or inducers within 7 days prior to the first dose of the investigational drug (or has taken these drugs for less than 5 half-lives), they cannot be enrolled. Patients using moderate CYP3A inhibitors can be considered for the study after at least a 7-day washout period.
  • Anticoagulation treatment with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) is required within 7 days after the first dose of the investigational drug or receiving anticoagulation therapy.
  • Pregnant or breastfeeding women
  • Hypersensitivity to any investigational drug
  • Any mental or cognitive impairment that may limit their understanding, execution, and compliance with the informed consent form and the study.
  • Subjects with drug abuse and alcoholism

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hongmei Jing contact

86 010-82266781

hongmei_jing@163.com

China1 site, 1 recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality

    Hongmei Jing, 010-82266778, hongmei_jing@163.com

    Recruiting

Other trials in China

About this study

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

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.

Being tested
Pomalidomide, Orelabrutinib, Zuberitamab
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PomalidomideDrug

    Also called Induction phase

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

  • OrelabrutinibDrug

    Also called Induction phase

    150mg/day PO once daily

  • ZuberitamabDrug

    Also called Induction phase

    375 mg/m² IV on day 1/cycle

  • ZuberitamabDrug

    Also called Maintenance phase

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

Study groups in NCT07257510
Study groupRoleWhat they receive
Pomalidomide + Orelabrutinib + Zuberitamab and Orelabrutinib + Zuberitamab MaintenanceExperimental1. In induction phase, patients will receive pomalidomide 4mg/day PO once daily day1-12/cycle; orelabrutinib 150 mg/day PO once daily; and zuberitamab 375 mg/m² IV on day 1/cycle, every 28 day per cycle for 6 cycles. 2. In maintenance phase, Patients with MRD negative (≤10-5) after induction therapy will recieve orelabrutinib 150 mg/day PO once daily for 18cycles and zuberitamab 375 mg/m² IV on day 1 of cycle 7, 10, 13, 16, 19 and 22, every 28 day per cycle.
Receives: Drug: Pomalidomide; Drug: Orelabrutinib; Drug: Zuberitamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Minimum residual disease (MRD) rate

    After 6 cycles of the pomalidomide combined with orelabrutinib and zuberitamab (POZ) regimen, the proportion of patients with undetectable minimal residual disease (MRD) (≤10-5) as evaluated by the high-throughput sequencing (NGS) platform.

    Measured: 6 months

Secondary outcomes (7)

  1. MRD rate

    The proportion of patients with undetectable minimal residual disease (MRD) (≤10-5) as evaluated by the high-throughput sequencing (NGS) platform.

    Measured: 3 months

  2. MRD rate

    The proportion of patients with undetectable minimal residual disease (MRD) (≤10-5) as evaluated by the high-throughput sequencing (NGS) platform.

    Measured: 12 months

  3. MRD rate

    The proportion of patients with undetectable minimal residual disease (MRD) (≤10-5) as evaluated by the high-throughput sequencing (NGS) platform.

    Measured: 18 months

  4. MRD rate

    The proportion of patients with undetectable minimal residual disease (MRD) (≤10-5) as evaluated by the high-throughput sequencing (NGS) platform.

    Measured: 24 months

  5. Overall Response Rate

    Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

    Measured: up to 3 years

  6. Progression-free survival

    Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

    Measured: up to 3 years

  7. Overall survival

    Overall survival was defined as the time from the date of randomization to the date of death from any cause.

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study start1 Aug 2025
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07257510
Sponsor's protocol ID
POZ
Status last verified
Aug 2025
First submitted
20 Nov 2025
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Pomalidomide, Orelabrutinib and Zuberitamab in people with Mantle Cell Lymphoma (MCL) and POZ, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hongmei Jing (86 010-82266781, hongmei_jing@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minimum residual disease (MRD) rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07257510.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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