Recruiting NCT06481826
Glofitamab in Chinese Patients With R/R DLBCL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Glofitamab.
- Who it may be relevant to
- Registry conditions: DLBCL - Diffuse Large B Cell Lymphoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study to Evaluate Glofitamab as Single Agent in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Overview
This study will evaluate the safety and efficacy of glofitamab as a single agent in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy.
Interventions
- Drug Glofitamab
Glofitamab given in standard dosage
Primary outcome measures
- PFS [Time frame: 1 year]
Secondary outcome measures (5)
- OS [Time frame: 2 year]
- CR rate [Time frame: 6 weeks, 18 weeks, 36 weeks]
- ORR [Time frame: 6 weeks, 18 weeks, 36 weeks]
- DOR [Time frame: 2 year]
- AE [Time frame: 2 year]
Eligibility criteria
Inclusion criteria
- Histologically-confirmed DLBCL
- Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy
- Participants must have measurable disease
Exclusion criteria
- Pregnancy or breastfeeding
- Patient with known active infection, or reactivation of a latent infection
- Patient with active autoimmune disease or immune deficiency
- severe organ failure：LVEF<40%；DLCO<40%；eGFR<30ml/min；Bilirubin≥3ULN
- Patients who are dependent on the sponsor, the investigator or the trial site
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Publications
- Dickinson MJ, Carlo-Stella C, Morschhauser F, Bachy E, Corradini P, Iacoboni G, Khan C, Wrobel T, Offner F, Trneny M, Wu SJ, Cartron G, Hertzberg M, Sureda A, Perez-Callejo D, Lundberg L, Relf J, Dixon M, Clark E, Humphrey K, Hutchings M. Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022 Dec 15;387(24):2220-2231. doi: 10.1056/NEJMoa2206913. Epub 2022 Dec 11. PMID 36507690
- Birtas Atesoglu E, Gulbas Z, Uzay A, Ozcan M, Ozkalemkas F, Dal MS, Kalyon H, Akay OM, Deveci B, Bekoz H, Sevindik OG, Toptas T, Yilmaz F, Koyun D, Alkis N, Alacacioglu I, Sonmez M, Yavasoglu I, Tombak A, Mehtap O, Kurnaz F, Yuce OK, Karakus V, Turgut M, Kurekci DD, Ayer M, Keklik M, Buyuktas D, Ozbalak M, Ferhanoglu B. Glofitamab in relapsed/refractory diffuse large B-cell lymphoma: Real-world da PMID 37211991
- Song YQ, Zhang HL, Huang HQ, Zhang QY, Jing HM, Wang C, Wu C, Li DH, Dai Y, Humphrey K, Zhu J. Glofitamab monotherapy induces high complete response rates and manageable safety in Chinese patients with heavily pretreated relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2024 Apr 1;109(4):1269-1273. doi: 10.3324/haematol.2023.283802. No abstract available. PMID 37855035
Identifiers
NCT: NCT06481826 · Glofitamab-1