Gut Microbiome in DLBCL Treated With Glofitamab
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically/cytologically confirmed diagnosis of DLBCL
Is being planned to received Glofitamab
Be able to provide written informed consent
Disqualifiers
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.
Concurrent second malignancy.
Trial population
DLBCL patients planned to treated with glofitamab
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Gut microbiome analysis
Other interventionGut microbiome analysis would be performed before and after glofitamab treatment in DLBCL patients.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: GM group1 intervention
Trial outcomes
Primary outcomes
1
Changes in gut microbiome
Characterization of the compositional and functional modifications of gut microbiome in DLBCL patients treated with glofitamab from baseline to 1 year after the end of treatment.
Time frame
2 yearsSecondary outcomes
1
Correlation between gut microbiome and therapy outcomes in terms of response and toxicity
Correlation between gut microbiome and therapy outcomes in terms of response and toxicity
Time frame
2 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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