PET Imaging Targeting Granzyme B Predicts Immunotherapy Efficacy in Diffuse Large B-cell Lymphoma

NCT06755775 | Recruiting DMC

• 1 other identifier: RuijinH 2024-254
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the predictive value of PET imaging targeting granzyme B on the outcome of patients with diffuse large B lymphoma receiving immunotherapy.

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

PET/CT; Granzyme B; immunotherapy

Outcome Measures

Primary Outcomes (2)

• The value of PET imaging targeting granzyme B in predicting the efficacy of immunotherapy for diffuse large B-cell lymphoma

  The value of PET imaging targeting granzyme B in predicting the efficacy of immunotherapy for diffuse large B-cell lymphoma

  Baseline and 2 weeks after treatment

• Standardized uptake value (SUV)

  SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions

  Baseline and 2 weeks after treatment

Secondary Outcomes (2)

• Progress free suivival

  3 years

• Overall survival

  3 years

Study Arms (1)

patients diagnosed with DLBCL who will receive immunotherapy (CAR-T, glofitamab, iR2)

Eligibility Criteria

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

Study Population

Chinese patient with pathologically confirmed diffuse large B-cell lymphoma

You may qualify if:

• Pathologic diagnosis of DLBCL
• Patient's general condition is good and survival is expected to be greater than six months
• Signed and dated informed consent form

You may not qualify if:

• Combined with other malignant tumors
• Patients with serious medical conditions who, in the opinion of the investigator, are not suitable for participation in this clinical study
• Pregnant women and women at risk of pregnancy, breastfeeding women
• poor compliant

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lipodystrophy, Congenital Generalized

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipodystrophy; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Xinyi Zhu

CONTACT

19121913585; zxy16zz@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 1, 2025
• Study Start: July 23, 2024
• Primary Completion (Estimated): July 23, 2029
• Study Completion (Estimated): July 23, 2029
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)