Hematologic CancerTTV-CARTNCT04822974
TORQUETENOVIRUS IN CAR-T THERAPY: PREDICTION OF THE CRS
A study testing blood collection in people with Hematologic Cancer, run by Institut Paoli-Calmettes.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Cancer
- What is being tested?
- blood collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy/breast feeding.
- Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: TORQUETENOVIRUS IN CAR-T THERAPY: PREDICTION OF THE RISK OF CYTOKINE RELEASE SYNDROME AND DIFFERENTIAL DIAGNOSIS WITH INFECTION
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.
Read the 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
- Conditions
- Hematologic Cancer
- Being tested
- blood collection
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood collectionOther
longitudinally collection of blood samples for each patient included.
| Study group | Role | What they receive |
|---|---|---|
| STUDY ARM | Experimental | blood samples collection Receives: Other: blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma viral load and TTV replication kinetics
comparaition between before during and after CART
Measured: d0, d1, d3, d5, d7, d10, d14, d21, d28, d60 and d90 after CAR-T Cell treatment
Secondary outcomes (3)
Plasma viral load and CMV replication kinetics
comparaition between before during and after CART
Measured: d0, d14, d28, d60 and d90 after CAR-T Cell treatment
infections
Reported infections during the study
Measured: 100 days
Cytokines
Cytokines comparison between samples
Measured: d0, d3, d7, d10 and d14 after CAR-T Cell treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 May 2021 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematologic CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valencia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822974
- Sponsor's protocol ID
- TTV-CART-IPC 2020-063
- Acronym
- TTV-CART
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benzaquen A, Gimenez E, Iacoboni G, Guerreiro M, Hernani R, Albert E, Carpio C, Balaguer A, Perez A, S de la Asuncion C, Sanchez-Salinas MA, Chorao P, Pinana JL, Beas F, Montoro J, Hernandez-Boluda JC, Facal A, Ferrer B, Villalba M, Amat P, Gomez MD, Campos D, Terol MJ, Sanz J, Barba P, Navarro D, Solano C. Torque Teno Virus plasma DNA load: a novel prognostic biomarker in CAR-T therapy. Bone Marrow Transplant. 2024 Jan;59(1):93-100. doi: 10.1038/s41409-023-02114-0. Epub 2023 Nov 2.
PubMed 37919456
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TORQUETENOVIRUS IN CAR-T THERAPY: PREDICTION OF THE RISK OF CYTOKINE RELEASE SYNDROME AND DIFFERENTIAL DIAGNOSIS WITH INFECTION
- ClinicalTrials.gov ID
- NCT04822974
- Acronym / sponsor ID
- TTV-CART / TTV-CART-IPC 2020-063
- Conditions
- Hematologic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valencia
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STUDY ARM | Experimental | Other: blood collectionblood samples collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy/breast feeding.
- Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood collectionlongitudinally collection of blood samples for each patient included. | Other | STUDY ARM |
Primary outcome
Plasma viral load and TTV replication kinetics
Time frame: d0, d1, d3, d5, d7, d10, d14, d21, d28, d60 and d90 after CAR-T Cell treatment
comparaition between before during and after CART
3 secondary outcomes
Plasma viral load and CMV replication kinetics
Time frame: d0, d14, d28, d60 and d90 after CAR-T Cell treatment
infections
Time frame: 100 days
Cytokines
Time frame: d0, d3, d7, d10 and d14 after CAR-T Cell treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Derived from this study: PubMed 37919456Benzaquen A, Gimenez E, Iacoboni G, Guerreiro M, Hernani R, Albert E, Carpio C, Balaguer A, Perez A, S de la Asuncion C, Sanchez-Salinas MA, Chorao P, Pinana JL, Beas F, Montoro J, Hernandez-Boluda JC, Facal A, Ferrer B, Villalba M, Amat P, Gomez MD, Campos D, Terol MJ, Sanz J, Barba P, Navarro D, Solano C. Torque Teno Virus plasma DNA load: a novel prognostic biomarker in CAR-T therapy. Bone Marrow Transplant. 2024 Jan;59(1):93-100. doi: 10.1038/s41409-023-02114-0. Epub 2023 Nov 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing blood collection in people with Hematologic Cancer, run by Institut Paoli-Calmettes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DOMINIQUE GENRE, DR (0491223778, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma viral load and TTV replication kinetics (time frame: d0, d1, d3, d5, d7, d10, d14, d21, d28, d60 and d90 after CAR-T Cell treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04822974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.