Clinical trial · Observational

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

NCT07198373CI-TRIAL-00095979not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
B Cell Lymphoma	B-Cell Malignant Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Maintenance Therapy Group	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
Maintenance Therapy Group
interventionNames
1. Drug: Maintenance Therapy Group

Primary outcomes (1)

measure
Progression-free survival (PFS) rate at 24 months post-administration
timeFrame
From date ofrandomization untilhe date of first documented progression , assessed up to 24 months

Secondary outcomes (2)

measure
Progression-Free Survival (PFS)
timeFrame
The time from the start of cell infusion to the first assessment of progression or death from any cause， assessed up to 5 years
measure
Overall Survival (OS)
timeFrame
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

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* (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.

Exclusion Criteria:

* (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.

  1. 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.

References

Publications (0)

Data not yet available

No reference posted for this study.