A Study of Efficacy and Safety of Glofitamab in Combination With Salvage Therapy in a Real-world Setting in Chinese Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.

NCT06497452 | Recruiting FDA Drug

• 1 other identifier: GLOFTST
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy and safety in the real-world settings of glofitamab in combination with salvage therapy among Chinese adult patients with relapsed or refractory B-cell non-hodgkin lymphoma.

Conditions

B-cell Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Best Complete Response Rate (bCRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

  Baseline up to EOT (approximately 9 months)

Secondary Outcomes (7)

• Best Overall Response Rate (bORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

  Baseline up to EOT (approximately 9 months)

• Duration of Response (DoR)

  From the date of the first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 24 months)

• Duration of Complete Response (DoCR)

  From the date of the first occurrence of a documented CR to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 24 months)

• PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

  Baseline up to end of study (approximately 24 months)

• Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

  From the start of glofitamab treatment to any treatment failure including disease progression, relapse, initiation of new antilymphoma therapy (NALT), or death from any cause, which occurs first (up to approximately 24 months)

Study Arms (1)

Observational Cohort

Drug: Glofitamab

Interventions

Glofitamab DRUG

Glofitamab will be administered at the discretion of the physician per local clinical practice and local labeling

Observational Cohort

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

Participants who will be treated with glofitamab (known as being recommended and having the intention to be treated with glofitamab at the time of signing informed consent) or have initiated glofitamab treatment within three months prior to enrollment and after the indication approval will be observed in this study.

You may qualify if:

• Be diagnosed as B-NHL
• Relapse or refractory to previous treatment
• Participants who will be treated with glofitamab

You may not qualify if:

• Participant who currently participates in or with plan to participate in any interventional clinical trial
• Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

glofitamab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Haiwen Huang

CONTACT

0512-80668050; huanghaiwen@suda.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 11, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: June 1, 2026
• Last Updated: July 11, 2024

Record last verified: 2024-06

Locations

CN (1)