Exosomes and Immunotherapy in Non-Hodgkin B-cell Lymphomas
ExoReBLy
Exosomes and Resistance to Immunotherapy in Aggressive Non-Hodgkin B-cell Lymphomas (B-NHL)
1 other identifier
interventional
90
1 country
1
Brief Summary
Diffuse large B-cell lymphomas (DLBCL) are highly aggressive and heterogeneous B-cell lymphoma that would imminently be fatal without treatment. Monoclonal anti-CD20 antibody, rituximab, in combination of CHOP chemotherapy (R-CHOP) is widely used with favourable results. Although more than half of patients achieve long-term remission, many are not cured with this immunotherapy. Suboptimal response and/or resistance to rituximab have remained a challenge in the therapy of DLBCL but also of all B-NHL. Exosomes are microvesicles released from tumor B cells that are found in plasma of patients with B-NHL. Exosomes carry therapeutic targets (as CD20, PDL-1) and could act as "decoy-receptors" for immunotherapy. Our objective is to precise, in aggressive B-NHL, the role of exosomes in immunotherapy escape.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2019
CompletedFirst Posted
Study publicly available on registry
June 14, 2019
CompletedStudy Start
First participant enrolled
July 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2025
CompletedJuly 25, 2022
July 1, 2022
6 years
June 11, 2019
July 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quantification of CD20 and PDL-1 in exosomes purified from cell cultures of DLBCL human cell lines and from Healthy volunteers
From D0 until the end of the inclusion period (36 months)
Month 36
Secondary Outcomes (1)
Evaluation if peripheral exosomes can be used as novel diagnostic biomarkers in DLBCL
Month 36
Study Arms (2)
patients with DLBCL
EXPERIMENTALHealthy volunteers
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- patients over 18 years old with DLBCL at diagnostic or relapsed patients after R-CHOP therapy.
- Healthy volunteers over 18 years old
You may not qualify if:
- other B cell diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Limoges
Limoges, 87042, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2019
First Posted
June 14, 2019
Study Start
July 2, 2019
Primary Completion
July 2, 2025
Study Completion
July 2, 2025
Last Updated
July 25, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share