B Cell Lymphoma
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Beijing GoBroad Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) rate at 24 months post-administration | From date ofrandomization untilhe date of first documented progression , assessed up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) | The time from the start of cell infusion to the first assessment of progression or death from any cause， assessed up to 5 years |
| Overall Survival (OS) | 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 |
Contacts
Primary Contactkai Hu
Outcome results
None listed