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Trial Title:
Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With CAR-T Cell Therapy
NCT ID:
NCT05725720
Condition:
Diffuse Large B Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Conditions: Keywords:
Gut microbiome
CAR T-cell therapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Gut microbiome analysis
Description:
Characterization of the compositional and functional modifications of gut microbiome in
patients affected by lymphoma undergoing therapy with CAR-T cells from baseline until the
restaging after 18 months from the CAR-T cell infusion
Summary:
Despite impressive outcomes in selected patients, significant heterogeneity in clinical
response to CAR-T cell therapy remains. The gut microbiome (GM) has recently emerged as
one of the key modifiable factors of prognosis and response to treatment in cancer
patients, with high-diversity profiles rich in health-associated taxa while poor in
pathobionts generally associated with better response and longer survival. Currently, it
is unknown if GM also modulates anti-tumor responses to CAR-T cells and related
toxicities in lymphomas.
Criteria for eligibility:
Study pop:
Up to 90 relapsed/refractory diffuse large B-cell lymphoma adult (≥18 years) patients
undergoing CAR-T cell therapy will be enrolled over 3 years, treated and followed up with
fecal sample collection until 18 months after CAR-T cell infusion.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age ≥18 years.
2. Patients affected by histologically confirmed DLBCL.
3. Patients amenable for CAR-T cell therapy as for clinical approved indication
(commercial products).
4. Patients must 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Institute Of Hematology "Seràgnoli"
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Pier Luigi Zinzani, MD
Phone:
+39 051 636
Phone ext:
4042
Email:
pierluigi.zinzani@unibo.it
Investigator:
Last name:
Pier Luigi Zinzani, MD
Email:
Principal Investigator
Start date:
March 23, 2023
Completion date:
December 2027
Lead sponsor:
Agency:
University of Bologna
Agency class:
Other
Collaborator:
Agency:
Associazione Italiana per la Ricerca sul Cancro
Agency class:
Other
Collaborator:
Agency:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Agency class:
Other
Source:
University of Bologna
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05725720
