Cytomegalovirus InfectionsCMV CAR-TNCT06058858
Incidence and Risks Factors of CMV Reactivation in Patients Receiving of CAR-T Cells for Acute Leukemia and Lymphoma Relapse, a Cohort Study Analysis
An observational study of Cytomegalovirus Infections and Acute Leukemia, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Letermovir is approved for the primary prevention of Cytomegalovirus (CMV) reactivation and infection in hematopoietic stem cell transplant recipients. Letermovir may be beneficial in other clinical presentation where CMV reactivates and may alter clinical outcomes. Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Cytomegalovirus Infections, Acute Leukemia, B Cell Lymphoma
- How many people
- 250 participants
- Where
- 3 sitesFrance
- Study dates
- 17 Apr 2024to 17 Apr 2025
- Phase
- Observational
- 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 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Paediatric and adult patient treated by CAR-T cells
Who may be able to join
- Provide written non-opposition from the patient signed by investigator
- If the patient is a minor, provide written non-opposition from both parents and child (if age appropriate to collect their non-objection) or child and the legal representative in case only one parent is alive, signed by investigator
- Provide written consent form signed by patient and investigator
- If the patient is a minor, provide written consent form signed by investigator and both parents or signed by investigator and the legal representative in case only one parent is alive
Who cannot join
- CMV seronegative patients
- Lack of affiliation to a social security scheme (as a beneficiary or assignee)
- Patients under guardianship / curatorship
- Patient under AME (state medical aid)
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Hopital Robert Debré - APHP
Paris
Marie-Emilie Dourthe, MD
- Recruiting
Hopital Saint Louis - APHP - Service d'hématologie " Unité Adolescents et jeunes adultes "
Paris
Florence Rabian, MD
- Recruiting
Hopital Saint-Louis - APHP - Service d'éhamotologie - oncologie
Paris
Roberta Di Blasi, MD
About this study
Letermovir is approved for the primary prevention of Cytomegalovirus (CMV) reactivation and infection in hematopoietic stem cell transplant recipients. Letermovir may be beneficial in other clinical presentation where CMV reactivates and may alter clinical outcomes. Recently Chimeric Antigen Receptor (CAR) T cells have been used for the treatment of refractory acute leukemia and B cell lymphoma. Reactivation of chronic viral infections, in particular those belonging to the Herpesviridae family can therefore be observed following CAR-T cells treatment.According to first reports, Cytomegalovirus seems to be the main virus detected. Uncontrolled CMV reactivation leads to CMV disease requiring the use of antiviral drugs associated with either hematological toxicity (ganciclovir) or renal toxicity (foscarnet) and is usually associated with poor outcomes. In addition, CMV interplays with the immune system and decreases the immunosurveillance of tumor cells and facilitates the growth or reactivation of other opportunistic infections. Therefore, CMV reactivation could also impact the outcome of CART cells treatment by increasing the existing risk of opportunistic infections in CART cells recipients and thus by increasing morbidity, length stay or require intensive care. Imbalance of the immune system usually correlates with reactivation of persistent virus like Torquetenovirus (TTV), redondovirus or pegivirus found more frequently in Hematopoietic stem-cell transplantation (HSCT) patients or patients requiring intensive care. Whether reactivations of those persistent viruses are associated or precede CMV reactivation deserve careful investigation to identify as early as possible patients at high risk and who could benefit from antiviral preventive treatment.
The objective of this trial is to determine the incidence of CMV reactivation within 3 months after infusion of CAR-T cells in CMV seropositive patients with refractory acute leukemia or B-cell lymphoma.
- Conditions
- Cytomegalovirus Infections, Acute Leukemia, B Cell Lymphoma
- Medical subject headings
- Cytomegalovirus Infections, Lymphoma, B-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of CMV reactivation
Rate of CMV reactivation occurring within the first 3 months after CAR-T-cell infusion in paediatric and adult patients treated for refractory B cell acute lymphoblastic leukemia (B-ALL) and diffuse large B-cell lymphoma (DLBCL).
Measured: Up to 3 months after inclusion
Secondary outcomes (12)
Rate of CMV disease
Measured: Up to 3 months
Rate of anellovirus infection
Measured: Up to 3 months
Rate of pegivirus infection
Measured: Up to 3 months
Rate of redondovirus infection
Measured: Up to 3 months
Correlation between CMV reactivation and the occurrence of other bacterial or fungal infections
Measured: Up to 3 months
Correlation between CMV reactivation and the expansion of CAR-T cells
Measured: Up to 3 months
Correlation between CMV reactivation and other early viral persistent reactivations (anellovirus, pegivirus, redondovirus)
Measured: Up to 3 months
Rate of CMV reactivation in patients with acute leukemia
Measured: Up to 3 months
Rate of CMV reactivation in patients with lymphoma
Measured: Up to 3 months
Detection of mutations in the CMV DNA polymerase gene in patients under acyclovir or valacyclovir prophylaxis
Measured: Up to 3 months
Health related quality of life (HRQL)) of the study population with or without CMV activation
EQ-5D-5L scale (adult) EQ-5D-Y scale (child) First part describes 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) Second part is a visual analogue scale with a score varying from 0 to 100; the higher the score the better the state of health.
Measured: Up to 3 months
Cost of illness of CMV disease
Illness of CMV disease is defined by prolonged initial hospitalization, additional hospitalizations, increased surveillance in case of reactivation (consults and biological sampling), treatments)
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start17 Apr 2024
- Primary completion17 Apr 2025 (estimated)
- Study completion17 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058858
- Sponsor's protocol ID
- APH211589
- Acronym
- CMV CAR-T
- Status last verified
- Jul 2024
- First submitted
- 22 Sep 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risks Factors of CMV Reactivation in Patients Receiving of CAR-T Cells for Acute Leukemia and Lymphoma Relapse, a Cohort Study Analysis
- ClinicalTrials.gov ID
- NCT06058858
- Acronym / sponsor ID
- CMV CAR-T / APH211589
- Conditions
- Cytomegalovirus Infections, Acute Leukemia, B Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 17 Apr 2025 (estimated)
- Study completion
- 17 Apr 2025 (estimated)
- First posted
- 28 Sep 2023 (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.
Letermovir is approved for the primary prevention of Cytomegalovirus (CMV) reactivation and infection in hematopoietic stem cell transplant recipients. Letermovir may be beneficial in other clinical presentation where CMV reactivates and may alter clinical outcomes. Recently Chimeric Antigen Receptor (CAR) T cells have been used for the treatment of refractory acute leukemia and B cell lymphoma. Reactivation of chronic viral infections, in particular those belonging to the Herpesviridae family can therefore be observed following CAR-T cells treatment.According to first reports, Cytomegalovirus seems to be the main virus detected. Uncontrolled CMV reactivation leads to CMV disease requiring the use of antiviral drugs associated with either hematological toxicity (ganciclovir) or renal toxicity (foscarnet) and is usually associated with poor outcomes. In addition, CMV interplays with the immune system and decreases the immunosurveillance of tumor cells and facilitates the growth or reactivation of other opportunistic infections. Therefore, CMV reactivation could also impact the outcome of CART cells treatment by increasing the existing risk of opportunistic infections in CART cells recipients and thus by increasing morbidity, length stay or require intensive care. Imbalance of the immune system usually correlates with reactivation of persistent virus like Torquetenovirus (TTV), redondovirus or pegivirus found more frequently in Hematopoietic stem-cell transplantation (HSCT) patients or patients requiring intensive care. Whether reactivations of those persistent viruses are associated or precede CMV reactivation deserve careful investigation to identify as early as possible patients at high risk and who could benefit from antiviral preventive treatment.
The objective of this trial is to determine the incidence of CMV reactivation within 3 months after infusion of CAR-T cells in CMV seropositive patients with refractory acute leukemia or B-cell lymphoma.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Paediatric and adult patient treated by CAR-T cells
Key inclusion criteria (4 listed)
- Provide written non-opposition from the patient signed by investigator
- If the patient is a minor, provide written non-opposition from both parents and child (if age appropriate to collect their non-objection) or child and the legal representative in case only one parent is alive, signed by investigator
- Provide written consent form signed by patient and investigator
- If the patient is a minor, provide written consent form signed by investigator and both parents or signed by investigator and the legal representative in case only one parent is alive
Key exclusion criteria (4 listed)
- CMV seronegative patients
- Lack of affiliation to a social security scheme (as a beneficiary or assignee)
- Patients under guardianship / curatorship
- Patient under AME (state medical aid)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of CMV reactivation
Time frame: Up to 3 months after inclusion
Rate of CMV reactivation occurring within the first 3 months after CAR-T-cell infusion in paediatric and adult patients treated for refractory B cell acute lymphoblastic leukemia (B-ALL) and diffuse large B-cell lymphoma (DLBCL).
12 secondary outcomes
Rate of CMV disease
Time frame: Up to 3 months
Rate of anellovirus infection
Time frame: Up to 3 months
Rate of pegivirus infection
Time frame: Up to 3 months
Rate of redondovirus infection
Time frame: Up to 3 months
Correlation between CMV reactivation and the occurrence of other bacterial or fungal infections
Time frame: Up to 3 months
Correlation between CMV reactivation and the expansion of CAR-T cells
Time frame: Up to 3 months
Correlation between CMV reactivation and other early viral persistent reactivations (anellovirus, pegivirus, redondovirus)
Time frame: Up to 3 months
Rate of CMV reactivation in patients with acute leukemia
Time frame: Up to 3 months
Rate of CMV reactivation in patients with lymphoma
Time frame: Up to 3 months
Detection of mutations in the CMV DNA polymerase gene in patients under acyclovir or valacyclovir prophylaxis
Time frame: Up to 3 months
Health related quality of life (HRQL)) of the study population with or without CMV activation
Time frame: Up to 3 months
Cost of illness of CMV disease
Time frame: Up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infections and Acute Leukemia, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
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 4 inclusion and 4 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 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jérôme Le Goff, Pr (+33142499493, jerome.legoff@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of CMV reactivation (time frame: Up to 3 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2024.