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Not yet recruiting NCT07498920

Gut Microbiome in DLBCL Treated With Glofitamab

— Observational DLBCL Glofitamab Gut Biome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gut microbiome analysis.
Who it may be relevant to
Registry conditions: DLBCL, Glofitamab, Gut Biome. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With Glofitamab

Overview

The gut microbiome (GM) has recently emerged as one of the key modifiable factors of response and prognosis to immunotherapy in cancer patients. Currently, it is unknown if GM also modulates anti-tumor responses to T cell engagers (TCE) including glofitamab in DLBCL patients.

Detailed description

This is a prospective observation study to evaluate the role of gut microbiome in DLBCL patients treated by glofitamab.

Interventions

  • Other Gut microbiome analysis
    Gut microbiome analysis would be performed before and after glofitamab treatment in DLBCL patients.

Primary outcome measures

  • Changes in gut microbiome [Time frame: 2 years]
Secondary outcome measures (1)
  • Correlation between gut microbiome and therapy outcomes in terms of response and toxicity [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Histologically/cytologically confirmed diagnosis of DLBCL
  • Is being planned to received Glofitamab
  • Be able to provide written informed consent

Exclusion criteria

  • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
  • Concurrent second malignancy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07498920 · Glofitamab-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗