TORQUETENOVIRUS IN CAR-T THERAPY: PREDICTION OF THE CRS (TTV-CART)
Primary Purpose
Hematologic Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
blood collection
Sponsored by
About this trial
This is an interventional diagnostic trial for Hematologic Cancer
Eligibility Criteria
Inclusion Criteria:
- Adult patients (>=18 years).
- Patient going to be treated by CAR-T Cell therapy
- Able to comply with the protocol.
- Written informed consent.
- Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen
Exclusion Criteria:
- Pregnancy/breast feeding.
- Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
STUDY ARM
Arm Description
blood samples collection
Outcomes
Primary Outcome Measures
Plasma viral load and TTV replication kinetics
comparaition between before during and after CART
Secondary Outcome Measures
Plasma viral load and CMV replication kinetics
comparaition between before during and after CART
infections
Reported infections during the study
Cytokines
Cytokines comparison between samples
Full Information
NCT ID
NCT04822974
First Posted
March 24, 2021
Last Updated
March 26, 2021
Sponsor
Institut Paoli-Calmettes
Collaborators
Hospital Clínico Universitario de Valencia
1. Study Identification
Unique Protocol Identification Number
NCT04822974
Brief Title
TORQUETENOVIRUS IN CAR-T THERAPY: PREDICTION OF THE CRS
Acronym
TTV-CART
Official Title
TORQUETENOVIRUS IN CAR-T THERAPY: PREDICTION OF THE RISK OF CYTOKINE RELEASE SYNDROME AND DIFFERENTIAL DIAGNOSIS WITH INFECTION
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
Collaborators
Hospital Clínico Universitario de Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Torque Teno Virus (TTV) prevalence in the general population is very high (>90%) and has not been consistently confirmed to cause any disease. Kidney transplant studies seem to indicate that an elevated viremia could predict the risk of de-veloping an infectious process in the following weeks. An study of the influence of TTV as a predictive marker of infection in kidney transplant recipi-ents showed higher TTV levels, even 3 months before the infectious process, allowing the authors to postulate that the quantification of TTV could help to modulate the treatment of patients at risk. Publications of subsequent studies seem to confirm these data.In the field of hematopoietic stem cell transplantation (HSCT) few studies have analyzed the replication kinetics of TTV. There seems to be a drop in TTV plasma load after conditioning treatment, with a progressive increase in the first months post-transplant, in parallel with the number of lymphocytes. In early stages of HSCT, a relation-ship between TTV replication kinetics and the probability of developing an infection by CMV has also been described. Likewise, the possible relationship of TTV with other complications of HSCT, such as Epstein-Barr virus infection (EBV) or graft-versus-host disease (GvHD), have been reported. However, not every study conducted to date show this line of results.
Detailed Description
Torque Teno Virus (TTV) is the prototype of the Anelloviridae family-single chain and circular viruses. These viruses form about 70% of the human virome. TTV prevalence in the general population is very high (>90%) and has not been consistently confirmed to cause any disease. Kidney transplant studies seem to indicate that an elevated viremia could predict the risk of de-veloping an infectious process (bacterial, viral or fungal) in the following weeks. A group of research analyzed the influence of TTV as a predictive marker of infection in 169 kidney transplant recipi-ents. Patients with infection showed higher TTV levels, even 3 months before the infectious process, allowing its authors to postulate that the quantification of TTV could help to modulate the treatment of patients at risk (reducing immunosuppression, introducing or prolonging antimi-crobial prophylaxis). Publications of subsequent studies with greater number of patients seem to confirm these data. Likewise, in the specific case of CMV infection, the quantification of TTV in the early stages of kidney or liver transplantation also allows identification of patients at risk of developing a CMV infection. In the field of hematopoietic stem cell transplantation (HSCT) few studies have analyzed the replication kinetics of TTV. There seems to be a drop in TTV plasma load after conditioning treatment, with a progressive increase in the first months post-transplant, in parallel with the number of lymphocytes. In early stages of HSCT, a relation-ship between TTV replication kinetics and the probability of developing an infection by CMV has also been described. Likewise, the possible relationship of TTV with other complications of HSCT, such as Epstein-Barr virus infection (EBV) or graft-versus-host disease (GvHD), have been reported. However, not every study conducted to date show this line of results. An other research analyzed 2054 blood samples from 123 patients undergoing HSCT, finding no significant differences between TTV and post-transplant complications, such as viral reactivations (CMV, EBV or adenovirus), acute GvHD, relapse or mortality
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
STUDY ARM
Arm Type
Experimental
Arm Description
blood samples collection
Intervention Type
Other
Intervention Name(s)
blood collection
Intervention Description
longitudinally collection of blood samples for each patient included.
Primary Outcome Measure Information:
Title
Plasma viral load and TTV replication kinetics
Description
comparaition between before during and after CART
Time Frame
d0, d1, d3, d5, d7, d10, d14, d21, d28, d60 and d90 after CAR-T Cell treatment
Secondary Outcome Measure Information:
Title
Plasma viral load and CMV replication kinetics
Description
comparaition between before during and after CART
Time Frame
d0, d14, d28, d60 and d90 after CAR-T Cell treatment
Title
infections
Description
Reported infections during the study
Time Frame
100 days
Title
Cytokines
Description
Cytokines comparison between samples
Time Frame
d0, d3, d7, d10 and d14 after CAR-T Cell treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients (>=18 years).
Patient going to be treated by CAR-T Cell therapy
Able to comply with the protocol.
Written informed consent.
Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen
Exclusion Criteria:
Pregnancy/breast feeding.
Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DOMINIQUE GENRE, DR
Phone
0491223778
Email
drci.up@ipc.unicancer.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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TORQUETENOVIRUS IN CAR-T THERAPY: PREDICTION OF THE CRS
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