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NCT Number: NCT07472621

Real-World Effectiveness and Safety of Glofitamab in 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.

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Key information

Conditions

DLBCL - Diffuse Large B Cell Lymphoma Dendritic Cell Sarcoma, Interdigitating Hemic and Lymphatic Diseases Histiocytic Disorders, Malignant Histiocytosis Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Up to 6 months

    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).

Secondary outcomes

  1. Complete Response Rate (CR Rate)

    Time frame: Up to 6 months after enrollment

    Complete response (CR) rate is defined as the proportion of patients achieving complete response according to the Lugano criteria for lymphoma.

  2. Disease Control Rate (DCR)

    Time frame: Up to 6 months after enrollment

    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.

  3. DoR

    Time frame: Up to 24 months

    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.

  4. Progression-Free Survival (PFS)

    Time frame: Up to 24 months

    Progression-free survival (PFS) is defined as the time from initiation of glofitamab treatment to disease progression, relapse, or death from any cause.

  5. Overall Survival (OS)

    Time frame: Up to 24 months

    Overall survival (OS) is defined as the time from initiation of glofitamab treatment to death from any cause.

  6. Incidence of Adverse Events

    Time frame: From treatment initiation to 3 months after the last dose

    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.

  7. Time to Next Treatment (TTNT)

    Time frame: Up to 24 months

    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.

Other outcomes

  1. ctDNA-based Minimal Residual Disease (MRD)

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

    Minimal residual disease (MRD) will be evaluated using circulating tumor DNA (ctDNA) at baseline, before cycle 3, and at the end of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

keshu Dr zhou

CONTACT

[email protected]

+86 13674902391

Sponsors and collaborators

Lead sponsor

Henan Cancer Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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