Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-06 @ 11:29 AM
Study NCT ID:
NCT06058858
Status:
RECRUITING
Last Update Posted:
2024-07-17
First Post:
2023-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-04-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2023-09-22', 'studyFirstSubmitQcDate': '2023-09-22', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of CMV reactivation', 'timeFrame': 'Up to 3 months after inclusion', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Rate of CMV disease', 'timeFrame': 'Up to 3 months'}, {'measure': 'Rate of anellovirus infection', 'timeFrame': 'Up to 3 months'}, {'measure': 'Rate of pegivirus infection', 'timeFrame': 'Up to 3 months'}, {'measure': 'Rate of redondovirus infection', 'timeFrame': 'Up to 3 months'}, {'measure': 'Correlation between CMV reactivation and the occurrence of other bacterial or fungal infections', 'timeFrame': 'Up to 3 months'}, {'measure': 'Correlation between CMV reactivation and the expansion of CAR-T cells', 'timeFrame': 'Up to 3 months'}, {'measure': 'Correlation between CMV reactivation and other early viral persistent reactivations (anellovirus, pegivirus, redondovirus)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Rate of CMV reactivation in patients with acute leukemia', 'timeFrame': 'Up to 3 months'}, {'measure': 'Rate of CMV reactivation in patients with lymphoma', 'timeFrame': 'Up to 3 months'}, {'measure': 'Detection of mutations in the CMV DNA polymerase gene in patients under acyclovir or valacyclovir prophylaxis', 'timeFrame': 'Up to 3 months'}, {'measure': 'Health related quality of life (HRQL)) of the study population with or without CMV activation', 'timeFrame': 'Up to 3 months', 'description': '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.'}, {'measure': 'Cost of illness of CMV disease', 'timeFrame': 'Up to 3 months', 'description': 'Illness of CMV disease is defined by prolonged initial hospitalization, additional hospitalizations, increased surveillance in case of reactivation (consults and biological sampling), treatments)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cytomegalovirus Infections', 'Acute Leukemia', 'B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Paediatric and adult patient treated by CAR-T cells', 'healthyVolunteers': False, 'eligibilityCriteria': 'Common inclusion criteria :\n\n* Paediatric (1 to 18 years old) receiving CART-T cells treatment for refractory acute leukemia or B-cell lymphoma\n* Adult receiving CART-T cells treatment for refractory acute leukemia or B-cell lymphoma\n* CMV seropositive patients\n\nInclusion criteria : retrospective part\n\n* Provide written non-opposition from the patient signed by investigator\n* 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\n\nInclusion criteria : prospective part\n\n* Provide written consent form signed by patient and investigator\n* 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\n\nExclusion Criteria:\n\n* CMV seronegative patients\n* Lack of affiliation to a social security scheme (as a beneficiary or assignee)\n* Patients under guardianship / curatorship\n* Patient under AME (state medical aid)'}, 'identificationModule': {'nctId': 'NCT06058858', 'acronym': 'CMV CAR-T', 'briefTitle': 'Incidence and Risks Factors of CMV Reactivation in Patients Receiving of CAR-T Cells for Acute Leukemia and Lymphoma Relapse, a Cohort Study Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Incidence and Risks Factors of CMV Reactivation in Patients Receiving of CAR-T Cells for Acute Leukemia and Lymphoma Relapse, a Cohort Study Analysis', 'orgStudyIdInfo': {'id': 'APH211589'}}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Emilie Dourthe, MD', 'role': 'CONTACT'}], 'facility': 'Hopital Robert Debré - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florence Rabian, MD', 'role': 'CONTACT'}], 'facility': 'Hopital Saint Louis - APHP - Service d\'hématologie " Unité Adolescents et jeunes adultes "', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Roberta Di Blasi, MD', 'role': 'CONTACT'}], 'facility': "Hopital Saint-Louis - APHP - Service d'éhamotologie - oncologie", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Jérôme Le Goff, Pr', 'role': 'CONTACT', 'email': 'jerome.legoff@aphp.fr', 'phone': '+33142499493'}, {'name': 'Jérôme Lambert, Pr', 'role': 'CONTACT', 'email': 'jerome.lambert@u-paris.fr', 'phone': '+33142499742'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}