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

Efficacy and Safety of Glofitamab in the Real-World Treatment of Patients With Primary Refractory and Early Relapsed Diffuse Large B-Cell Lymphoma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: DLBCL - Diffuse Large B Cell Lymphoma

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Keshu Dr Zhou; Phone Number: +86 13674902391; Email: drzhouks77@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
      • Contact: Keshu Dr Zhou; Phone Number: +86 13674902391; Email: drzhouks77@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• Participants must meet all of the following criteria:

  1. Age ≥18 years at the time of treatment initiation.
  2. Histologically or pathologically confirmed diffuse large B-cell lymphoma (DLBCL).

  3. 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.

  4. Patients who plan to initiate a glofitamab-containing treatment regimen (either monotherapy or combination therapy) within 12 months after study initiation.
  5. Willing and able to comply with study follow-up and data collection requirements.

Exclusion Criteria:

• Participants meeting any of the following criteria will be excluded:

  1. Currently participating in, or planning to participate in, any interventional clinical trial.
  2. 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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response Rate (CR Rate)	Complete response (CR) rate is defined as the proportion of patients achieving complete response according to the Lugano criteria for lymphoma.	Up to 6 months after enrollment
Disease Control Rate (DCR)	Disease control rate (DCR) is defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) according to the Lugano criteria for lymphoma.	Up to 6 months after enrollment
DoR	Duration of response (DoR) is defined as the time from the first documentation of complete response (CR) or partial response (PR) to disease progression, relapse, or death from any cause.	Up to 24 months
Progression-Free Survival (PFS)	Progression-free survival (PFS) is defined as the time from initiation of glofitamab treatment to disease progression, relapse, or death from any cause.	Up to 24 months
Overall Survival (OS)	Overall survival (OS) is defined as the time from initiation of glofitamab treatment to death from any cause.	Up to 24 months
Incidence of Adverse Events	Safety will be evaluated by assessing the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and grade ≥3 adverse events according to CTCAE version 5.0.	From treatment initiation to 3 months after the last dose
Time to Next Treatment (TTNT)	Time to next treatment (TTNT) is defined as the time from initiation of glofitamab therapy to the start of the next line of anti-lymphoma treatment.	Up to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ctDNA-based Minimal Residual Disease (MRD)	Minimal residual disease (MRD) will be evaluated using circulating tumor DNA (ctDNA) at baseline, before cycle 3, and at the end of treatment.	Baseline, before cycle 3, and end of treatment (up to 6 months)

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 10, 2026
• Primary Completion (Estimated): March 7, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Lymphatic Diseases; Histiocytic Disorders, Malignant; Histiocytosis; Hemic and Lymphatic Diseases; Dendritic Cell Sarcoma, Interdigitating
• Other Study ID Numbers: 2025-674-IIT-REAL-GLO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No