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Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell Lymphoma

ConditionsMantle Cell Lymphoma (MCL)POZ
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University Third Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Pomalidomide

    Drug

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

  • Orelabrutinib

    Drug

    150mg/day PO once daily

  • Zuberitamab

    Drug

    375 mg/m² IV on day 1/cycle

  • Zuberitamab

    Drug

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

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: Pomalidomide + Orelabrutinib + Zuberitamab and Orelabrutinib + Zuberitamab MaintenanceExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame
6 months

Secondary outcomes

1

MRD rate

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

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
24 months

Other outcomes

Sponsors and contacts

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Peking University Third Hospital

Lead sponsor

Source ClinicalTrials.gov
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