The Effectiveness and Safety of Glofitamab in Real-World Clinical Practice Among Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter Study

NCT06656234 | Not Yet Recruiting FDA Drug

• 1 other identifier: GloReal
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the the efficacy and safety in the real-world settings of glofitamab among Chinese R/R DLBCL participants.

Conditions

Diffuse Large B Cell Lymphoma (DLBCL)

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma

  Baseline up to end of study (EOS) (approximately 48 months)

Secondary Outcomes (6)

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

  Baseline up to EOS (approximately 48 months)

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

  Baseline up to EOS (approximately 48 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 48 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 48 months)

• Time to Next Treatment (TTNT)

  From the start of glofitamab treatment to the initiation of next-line treatment (up to approximately 48 months)

Study Arms (1)

Cohort 1

Participants with relapsed or refractory (R/R) DLBCL who have started receiving glofitamab at physician's discretion in accordance with local clinical practice and/or labeling will be observed for safety and efficacy until death, withdrawal of consent, loss to follow-up or end of study whichever occurs first (up to approximately 4 years).

Drug: Glofitamab; Drug: Obinutuzumab

Interventions

Glofitamab DRUG

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

Cohort 1

Obinutuzumab DRUG

Obinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1.

Cohort 1

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 6 months prior to enrollment and after the indication approval will be observed in this study.

You may qualify if:

• Be diagnosed as R/R DLBCL
• 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 6 months prior to enrollment and after the indication approval will be observed in this study.

You may not qualify if:

• Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

glofitamab; obinutuzumab

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

Central Study Contacts

Weili Zhao

CONTACT

008602164370045; zwl_trial@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2028
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)