Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 8:02 PM
Study NCT ID:
NCT04056533
Status:
RECRUITING
Last Update Posted:
2024-08-28
First Post:
2019-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2019-08-13', 'studyFirstSubmitQcDate': '2019-08-13', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '1-year incidence of CMV-CTLs adverse events', 'timeFrame': 'From date of CMV-CTLs infusion to 1 year after transplant', 'description': 'Infusion reactions, causes of death, secondary graft failures and graft versus host disease (GVHD).'}, {'measure': 'CMV-CTLs persistence', 'timeFrame': 'From date of CMV-CTLs infusion to 2 months after infusion', 'description': 'Expansion of CMV-CTLs detected by flow cytometry.'}, {'measure': 'Immune reconstitution post-HAPLO', 'timeFrame': 'From date of transplant to day 180 post-transplant', 'description': 'CD3, CD4, CD8, B and NK lymphocyte counts in patient peripheral blood post-transplant (day 30, 60, 90 and 180) detected by flow cytometry.'}], 'primaryOutcomes': [{'measure': '100-days incidence of CMV infection', 'timeFrame': 'From date of CMV-CTLs infusion to 100 days after transplant', 'description': 'Viral load \\>200 copies in 1 sample'}], 'secondaryOutcomes': [{'measure': '1-year incidence of CMV specific antiviral drug use', 'timeFrame': 'From date of CMV-CTLs infusion to 1 year after transplant', 'description': 'If viral load \\>200 copies in 2 samples or \\>1000 in 1 sample, treatment with valganciclovir will be started.\n\nTime from CMV-CTLs infusion until valganciclovir start and days of valganciclovir.'}, {'measure': '1-year incidence of CMV disease', 'timeFrame': 'From date of CMV-CTLs infusion to 1 year after transplant', 'description': 'CMV disease P.Lungman criteria. CMV as primary cause of death.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Citomegalovirus', 'Haploidentical', 'Hematopoietic Stem Cell Transplantation'], 'conditions': ['CMV']}, 'descriptionModule': {'briefSummary': 'Cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). Recently, strategies based on immunotherapy adoptive cells (IAC) with anti-CMV Cytolitic T Lymphocytes (CMV-CTLs) has been incorporated to prevent or treat CMV after HSCT. The aim to study donor derived CMV-CTLs after haploidentical HSCT (HAPLO) as prophylaxis for CMV infection in transplant patients. CMV-CTLs will be administer at day 21 (+-7 days) post-HAPLO. CMV DNA levels with quantitative PCR will be weekly monitored.', 'detailedDescription': "In HAPLO, CMV infection and disease are more frequent than in other type of HSCT, this is related to delayed immune reconstitution after transplant increasing post-transplant infectious complications. Approximately 60% of patients reactivated CMV infection after HAPLO and 15%, developed CMV disease afecting organs and causing the death of the patient in 8% of CMV disease cases.\n\nIf patient and donor are eligible, it will take 1x10\\^9 cells from donor leukapheresis. Donor cells will be selected and procesed by CliniMACs PRODIGY and after 12h it will obtain 7mL of CMV-CTLs. It will use 6mL of CMV-CTLs to infused a dose of 1x10\\^5 cells/kg in our patient. The donor derived CMV-CTL cells will be transfused into the patients' intravenous line. The patients will receive the dose of CMV-CTL cells when they are sero-positive for CMV-DNA 21 (+- 7 days) days after transplant.\n\nThe CMV-DNA levels will be monitored weekly for at least 100 days after the transplant. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then the patient will receive treatment with anti-CMV comercial drugs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients who received an alogeneic stem cell transplantation from haploidentical donors (HAPLO).\n* Any source of stem cells (peripheral blood or bone marrow).\n* CMV-seropositive donors.\n* Negative pregnancy test in women.\n* Signed writen informed consent.\n* DONORS:\n\n 1. HLA haploidentical and CMV-seropositve donors.\n 2. Donor must be checked and suitable.\n 3. Signed writen informed consent.\n 4. Donor without active infection evidence at leukapheresis.\n\nExclusion Criteria:\n\n* Patients without haploidentical CMV-seropositive donors.\n* Patients who are not suitable for follow up visits.\n\nCMV-CTLs Infusion Criteria:\n\n* Hematopoiesis recovery at least partial (neutrophil counts \\>0.5x10\\^9/L in at least 3 consecutive samples post-transplant).\n\nCMV-CTLs NON-Infusion Criteria:\n\n* Patients receiving corticosteroid (dose of 0.5mg/kg/day of prednisone or equivalent) at infusion.\n* ECOG \\> or = 3.\n* Organic toxicities grade \\> or = 3.\n* Patients who received ATG, donor lymphocytes or alemtuzuamb, 28 days pre-infusion.\n* Patients with uncontroled infection defined by fevers and/or inestability and/or infection not resolved.\n* Persistent fevers 3 days before infusion.\n* Acute Graft Versus Host Disease (GVHD) grade II-IV.\n* Relapse or progression after transplant and before infusion day.\n* CMV reactivation/infection after transplant and before infusion day.\n\nPatients who don´t fill infusion criteria, after day 28 post-HAPLO, will be considered screening failures and will be out of the study.'}, 'identificationModule': {'nctId': 'NCT04056533', 'acronym': 'INMUNOCELL', 'briefTitle': 'Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Marqués de Valdecilla'}, 'officialTitle': 'Anti-CMV Pilot Clinical Trial: Prophylaxis of Cytomegalovirus Infection in Haploidentical Transplatation of Hematopoietic Progenitors With Adoptive Cell Inmunotherapy', 'orgStudyIdInfo': {'id': 'INMUNOCELL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CMV CTLs', 'description': '1x10\\^5 CMV-CTLs/kg', 'interventionNames': ['Biological: CMV CTLs']}], 'interventions': [{'name': 'CMV CTLs', 'type': 'BIOLOGICAL', 'description': 'The donor derived cytomegalovirus specific T lymphocytes (CMV-CTL) will be transfused to the patients. The patients will receive CMV-CTL cells when their donors are sero-positive for CMV-DNA 21 days after transplant. The CMV-DNA levels will be monitored weekly for at least 100 days after the HAPLO. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then they may be eligible to receive a CMV specific antiviral drug.', 'armGroupLabels': ['CMV CTLs']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santander', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'enrique ocio', 'role': 'CONTACT'}], 'facility': 'Hospital Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}], 'centralContacts': [{'name': 'Miriam Sanchez-Escamilla, MD', 'role': 'CONTACT', 'email': 'msanchez@idival.org', 'phone': '+34646393234'}, {'name': 'Lucía Lavín Alconero, Phd', 'role': 'CONTACT', 'email': 'eclinicos5@idival.org'}], 'overallOfficials': [{'name': 'Galo Peralta Fernandez, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Instituto de Investigación Marqués de Valdecilla'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Marqués de Valdecilla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}