DLBCL, Glofitamab, Gut Biome
Conditions
Brief summary
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
Gut microbiome analysis would be performed before and after glofitamab treatment in DLBCL patients.
Sponsors
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Histologically/cytologically confirmed diagnosis of DLBCL 2. Is being planned to received Glofitamab 3. Be able to provide written informed consent
Exclusion criteria
1. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results. 2. Concurrent second malignancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in gut microbiome | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between gut microbiome and therapy outcomes in terms of response and toxicity | 2 years | Correlation between gut microbiome and therapy outcomes in terms of response and toxicity |
Contacts
CONTACTJing Ruan
Outcome results
None listed