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Exploratory Study on the Efficacy of Zebutinib as Maintenance Therapy Following CAR-T Cell Therapy in Patients With Non-Hodgkin B-Cell Lymphoma

ConditionB Cell Lymphoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing GoBroad Hospital

About this trial

This study is a single-center, Phase IV clinical trial designed to collect and analyze data on the efficacy and safety of zanubrutinib as maintenance therapy following CAR-T cell therapy in subjects with non-Hodgkin B-cell lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(1) Age ≥ 18 years, no gender restrictions; (2) Expected survival time exceeding 12 weeks; (3) Cytologically or histopathologically confirmed diagnosis of non-Hodgkin B-cell lymphoma according to WHO 2016 criteria; (4) Platelet count ≥ 50 × 10⁹/L; (5) Currently undergoing or scheduled to initiate oral zanubrutinib maintenance therapy following autologous or allogeneic CAR-T cell therapy; (6) Able to understand this trial and has signed an informed consent form.

Disqualifiers

(1) Pregnant or lactating individuals; male subjects planning to conceive within one year of treatment or within one year after cell reinfusion, or whose partners plan to conceive within one year after cell reinfusion; (2) Individuals with medical conditions that affect their ability to sign a written informed consent form or comply with study procedures; or those unwilling or unable to adhere to study requirements; (3) Individuals deemed unsuitable for participation in this trial by the investigator.

Pregnant or lactating individuals; or male subjects planning to conceive within one year of treatment or within one year after cell infusion, or whose partners plan to conceive within one year after cell infusion; (2) Individuals with medical conditions that prevent signing a written informed consent form or complying with study procedures; or those unwilling or unable to comply with study requirements; (3) Individuals deemed unsuitable for this trial by the investigator.

Trial population

Patients who achieve remission (complete or partial) at the 3-month post-CAR-T infusion assessment

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Maintenance Therapy Group

    Drug

    Patients achieving remission (complete or partial) at the 3-month post-CAR-T infusion assessment receive oral zanubrutinib capsules for maintenance therapy for 2 years.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Maintenance Therapy Group1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS) rate at 24 months post-administration

Time frame
From date ofrandomization untilhe date of first documented progression , assessed up to 24 months

Secondary outcomes

1

Progression-Free Survival (PFS)

Time frame
The time from the start of cell infusion to the first assessment of progression or death from any cause， assessed up to 5 years
2

Overall Survival (OS)

Time frame
From date of randomization untilhe date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing GoBroad Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: