Real-World Effectiveness and Safety of Glofitamab in Primary Refractory and Early Relapsed Diffuse Large B-Cell Lymphoma

NCT07472621 | Not Yet Recruiting

• 1 other identifier: 2025-674-IIT-REAL-GLO
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, observational, non-interventional real-world study that will not alter participants' routine clinical care. Approximately 20 eligible patients with diffuse large B-cell lymphoma (DLBCL) will be enrolled. Treatment decisions will be made by the treating physician based on standard clinical practice and may include glofitamab monotherapy or glofitamab-based combination regimens, such as glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) or glofitamab plus polatuzumab-based therapy (Glofit-Pola). The study will collect baseline characteristics (including age, sex, medical history, and molecular subtype), treatment information, laboratory test results, adverse events, and survival follow-up data. Circulating tumor DNA (ctDNA) testing will be performed to assess minimal residual disease (MRD) in peripheral blood. When clinically indicated, cerebrospinal fluid samples may be collected to measure drug concentration. All personal information will be kept strictly confidential. Identifiable information will be removed and replaced with coded study numbers. Medical records will be maintained at the study site and accessed only by authorized research personnel. Representatives from the sponsor, ethics committee, or regulatory authorities may review study records as required. Study results will be published in aggregated form without including any information that could identify individual participants. Study data and personal information will be used solely for research purposes.

Conditions

DLBCL - Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Overall response rate (ORR) is defined as the proportion of patients achieving complete response (CR) or partial response (PR) according to the Lugano criteria for lymphoma. The primary analysis will evaluate ORR at the end of treatment (EOT).

  Up to 6 months

Secondary Outcomes (7)

• Complete Response Rate (CR Rate)

  Up to 6 months after enrollment

• Disease Control Rate (DCR)

  Up to 6 months after enrollment

• DoR

  Up to 24 months

• Progression-Free Survival (PFS)

  Up to 24 months

• Overall Survival (OS)

  Up to 24 months

Other Outcomes (1)

• ctDNA-based Minimal Residual Disease (MRD)

  Baseline, before cycle 3, and end of treatment (up to 6 months)

Study Arms (1)

Glofitamab-Based Therapy Cohort

Patients with diffuse large B-cell lymphoma (DLBCL) receiving glofitamab-based therapy in routine clinical practice will be included in this cohort. Treatment regimens are determined by the treating physicians and may include glofitamab monotherapy or glofitamab in combination with chemotherapy or other agents (e.g., GemOx or polatuzumab-based regimens). Clinical data, treatment response, safety outcomes, and circulating tumor DNA (ctDNA) measurements will be prospectively collected and analyzed.

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

The study population will include adult patients (≥18 years) with histologically confirmed diffuse large B-cell lymphoma (DLBCL) who have primary refractory disease or early relapse after first-line therapy. Eligible patients are those who plan to initiate a glofitamab-containing treatment regimen (either as monotherapy or in combination with other agents) in routine clinical practice. Patients will be enrolled from participating centers and followed prospectively to evaluate treatment outcomes and safety in a real-world setting.

You may qualify if:

• Participants must meet all of the following criteria:
• Age ≥18 years at the time of treatment initiation.
• Histologically or pathologically confirmed diffuse large B-cell lymphoma (DLBCL).
• Patients with primary refractory disease or early relapse, defined as:
• Failure to achieve complete response (CR) after at least 4 cycles of first-line induction therapy, or
• Relapse confirmed by imaging within 12 months after achieving CR following first-line therapy.
• Patients who plan to initiate a glofitamab-containing treatment regimen (either monotherapy or combination therapy) within 12 months after study initiation.
• Willing and able to comply with study follow-up and data collection requirements.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded:
• Currently participating in, or planning to participate in, any interventional clinical trial.
• Any condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study (e.g., inability to complete follow-up, safety concerns, or significant comorbidities).

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan cancer hospital

Zhengzhou, Henan, 450008, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Circulating tumor DNA (ctDNA)

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Condition Hierarchy (Ancestors)

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

Central Study Contacts

keshu Dr zhou

CONTACT

+86 13674902391; drzhouks77@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Department of Hematology

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 16, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): March 7, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)