Real-World Study of Bispecific Antibody in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
A Real-World Study on the Efficacy and Safety of Bispecific Antibody in the Treatment of Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
B-cell non-Hodgkin lymphoma (B-NHL) is the most common type of lymphoma. Although first-line R-CHOP can cure a proportion of patients, approximately 30%-40% relapse or become refractory (R/R). CD20xCD3 bispecific antibodies, represented by glofitamab, have shown significant efficacy in clinical trials. However, large-scale real-world efficacy and safety data in Chinese clinical practice are still lacking, particularly regarding combination with different regimens and use in the relapsed population.
This is a prospective, multicenter, observational registry study evaluating the efficacy and safety of CD20xCD3 bispecific antibody-containing regimens in patients with relapsed or refractory B-cell non-Hodgkin lymphoma in a real-world setting. Efficacy is assessed using the Lugano 2014 response criteria. The primary endpoint is best objective response rate (ORR).
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
Study design: Prospective, multicenter, observational (non-interventional) registry study.
Population: Patients aged >=18 years with histologically confirmed B-cell non-Hodgkin lymphoma who are relapsed or refractory after at least one prior line of therapy and who receive a CD20xCD3 bispecific antibody-containing regimen after study initiation.
Efficacy evaluation: Lugano 2014 response criteria.
Primary endpoint: Best objective response rate (ORR).
Secondary endpoints: Complete response rate (CRR), disease control rate (DCR), duration of response (DOR), time to next treatment (TTNT), progression-free survival (PFS), overall survival (OS), and safety.
Exploratory endpoints: Subgroup analyses by combination pattern (e.g., combined with chemotherapy or targeted agents) and special populations; correlation of biomarkers (e.g., peripheral blood lymphocyte subsets, T-lymphocyte mitochondrial immune analysis, cytokines) with efficacy and safety; and patient compliance and quality-of-life analyses based on electronic patient-reported outcomes (ePRO).
Planned enrollment: 200 participants. As a non-interventional study, no formal statistical hypothesis is tested; the sample size is based on the confidence-interval width method (expected ORR P=0.5, half-width d=0.07), yielding approximately 196 participants, rounded to 200.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Yanyan Liu
- Puhelinnumero: +86 13838176375
- Sähköposti: yyliu@zzu.edu.cn
Opiskelupaikat
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Henan
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Zhengzhou, Henan, Kiina
- Henan Cancer Hospital
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Ottaa yhteyttä:
- Yanyan Liu
- Puhelinnumero: +86 13838176375
- Sähköposti: yyliu@zzu.edu.cn
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
- Age >= 18 years at the start of treatment
- Histologically confirmed B-cell non-Hodgkin lymphoma
- Relapsed or refractory disease after at least one prior line of systemic therapy
- Planned to receive a CD20xCD3 bispecific antibody-containing regimen after study initiation
- Signed informed consent for the investigational treatment
Exclusion Criteria:
- Currently participating in, or planning to participate in, any interventional clinical trial
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
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R/R B-NHL treated with bispecific antibody
Patients with relapsed or refractory B-cell non-Hodgkin lymphoma who receive a CD20xCD3 bispecific antibody-containing regimen (e.g., glofitamab) in routine clinical practice.
This is a single observational cohort; no treatment is assigned by the study.
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Glofitamab, a CD20xCD3 bispecific monoclonal antibody, administered per real-world clinical practice and product labeling.
As an observational study, treatment is determined by the treating physician and not by the study protocol; the intervention of interest is recorded to describe the treated population.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Best Overall Response Rate (ORR)
Aikaikkuna: From treatment initiation until disease progression or start of new anti-lymphoma therapy, assessed up to approximately 2 years
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ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to the Lugano 2014 response criteria for malignant lymphoma.
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From treatment initiation until disease progression or start of new anti-lymphoma therapy, assessed up to approximately 2 years
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Disease Control Rate (DCR)
Aikaikkuna: From treatment initiation until disease progression, assessed up to approximately 2 years
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DCR is defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) per Lugano 2014 criteria.
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From treatment initiation until disease progression, assessed up to approximately 2 years
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Duration of Response (DOR)
Aikaikkuna: From first response until disease progression or death, assessed up to approximately 2 years
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DOR is defined as the time from the first documented CR or PR to the first documented disease progression or death from any cause, whichever occurs first, among responders.
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From first response until disease progression or death, assessed up to approximately 2 years
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Time to Next Treatment (TTNT)
Aikaikkuna: From treatment initiation until start of next therapy or death, assessed up to approximately 2 years
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TTNT is defined as the time from treatment initiation to the start of the next line of anti-lymphoma therapy or death from any cause, whichever occurs first.
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From treatment initiation until start of next therapy or death, assessed up to approximately 2 years
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Progression-Free Survival (PFS)
Aikaikkuna: From treatment initiation until disease progression or death, assessed up to approximately 2 years
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PFS is defined as the time from treatment initiation to the first documented disease progression per Lugano 2014 criteria or death from any cause, whichever occurs first.
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From treatment initiation until disease progression or death, assessed up to approximately 2 years
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Overall Survival (OS)
Aikaikkuna: From treatment initiation until death from any cause, assessed up to approximately 2 years
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OS is defined as the time from treatment initiation to death from any cause.
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From treatment initiation until death from any cause, assessed up to approximately 2 years
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Incidence of Adverse Events (Safety)
Aikaikkuna: From treatment initiation until 90 days after last dose, assessed up to approximately 2 years
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Safety is assessed by the incidence, severity, and type of adverse events (AEs) and serious adverse events (SAEs), including adverse events of special interest such as cytokine release syndrome (CRS), graded per NCI CTCAE and, for CRS, per ASTCT consensus criteria.
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From treatment initiation until 90 days after last dose, assessed up to approximately 2 years
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Complete Response Rate (CRR)
Aikaikkuna: From treatment initiation until disease progression or start of new therapy, assessed up to approximately 2 years
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CRR is defined as the proportion of participants achieving a best overall response of complete response (CR) per Lugano 2014 criteria.
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From treatment initiation until disease progression or start of new therapy, assessed up to approximately 2 years
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Yanyan Liu, Henan Cancer Hospital
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Patologiset prosessit
- Neoplasmat
- Sairauden ominaisuudet
- Immuunijärjestelmän sairaudet
- Neoplasmat histologisen tyypin mukaan
- Lymfaattiset sairaudet
- Lymfoproliferatiiviset häiriöt
- Immunoproliferatiiviset häiriöt
- Lymfooma, non-Hodgkin
- Lymfooma
- Patologiset tilat, merkit ja oireet
- Hemic- ja imusuutteet
- Toistuminen
- Lymfooma, B-solu
- glofitamab
Muut tutkimustunnusnumerot
- HNSZLYYNHL12
- 2026-254 (Muu tunniste: Henan Cancer Hospital Medical Ethics Committee)
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