Glofitamab in Chinese Patients With R/R DLBCL

NCT06481826 | Recruiting

• 1 other identifier: Glofitamab-1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

DLBCL - Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-free survival

  1 year

Secondary Outcomes (5)

• OS

  2 year

• CR rate

  6 weeks, 18 weeks, 36 weeks

• ORR

  6 weeks, 18 weeks, 36 weeks

• DOR

  2 year

• AE

  2 year

Study Arms (1)

treatment group

Glofitamab

Drug: Glofitamab

Interventions

Glofitamab DRUG

Glofitamab given in standard dosage

treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Relapsed/Refractory Diffuse Large B-Cell Lymphoma

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 data. Hematol Oncol. 2023 Oct;41(4):663-673. doi: 10.1002/hon.3174. Epub 2023 May 22.

  PMID: 37211991 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Interventions

glofitamab

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Jing Ruan

CONTACT

+8615201435860; 15201435860@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 1, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 years after the closure of the study
• Access Criteria: upon email request

Locations

CN (1)