Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT04781803
Status:
UNKNOWN
Last Update Posted:
2021-03-05
First Post:
2021-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080424', 'term': 'Cytokine Release Syndrome'}], 'ancestors': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-02-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-03', 'studyFirstSubmitDate': '2021-03-01', 'studyFirstSubmitQcDate': '2021-03-01', 'lastUpdatePostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cytokine Release Syndrome', 'timeFrame': 'day 0 to day 30', 'description': 'Presence of Fever, hypotension, hypoxemia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cyclosporin', 'Haploidentical', 'Outpatient'], 'conditions': ['Stem Cell Transplant Complications', 'Cytokine Release Syndrome']}, 'descriptionModule': {'briefSummary': 'Phase II, randomized controlled, unblinded clinical trial. Will evaluate whether the administration of oral cyclosporine started on day 0 of transplantation is effective in reducing the incidence of cytokine release syndrome (CRS) in patients who receive an outpatient haploidentical transplant.', 'detailedDescription': 'CRS is usually limited after the administration of post-transplant cyclosporine (PT-CsA) administered on days +3 and +4, however, there is no standard prevention or treatment regimen for CRS after haplo-TCPH and therapeutic behavior has usually been adopted.\n\nSample of 32 patients between the ages of 16 and 60 who receive their first haploidentical transplant at our center. In the control group, CsA 6 mg/kg orally divided into two doses per day starting in the morning on day +5 of the transplant, mycophenolic acid 1 gram orally (2 tablets of 500 mg) from day +5 post-transplant and post-transplant cyclophosphamide (PT-CY) at 50 mg/kg per day on days +3 and +4 and in the experimental group, CsA 6 mg/kg orally divided into two doses per day starting in the morning on day 0 after transplantation, mycophenolic acid 1 gram orally (2 tablets 500 mg) from day 0 post-transplant and PT-CY at 50 mg/kg per day on day +3 and +4.\n\nWill document the presence of CRS and its degree, as well as the need for hospitalization, associated infectious processes, and a day to recover neutrophils and platelets. Additionally, 4 blood samples will be taken from the patients to determine the level of cytokines and C-reactive protein.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 16-60 years of age who receive their first haploidentical transplant.\n\nExclusion Criteria:\n\n* Patients positive for the human immunodeficiency virus (HIV), Hepatitis B or C virus\n* Pregnancy or lactation\n* Patients with documented infection at the time of transplantation\n* Presence of previous autoimmune diseases\n* Inability to tolerate the oral route'}, 'identificationModule': {'nctId': 'NCT04781803', 'briefTitle': 'Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Dr. Jose E. Gonzalez'}, 'officialTitle': 'Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome in Outpatient Haploidentical Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'HE21-00003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Cyclosporine 6 mg/kg orally divided into two doses per day starting in the morning on day 0 after transplantation, mycophenolic acid 1 gram orally (2 tablets 500 mg) from day 0 post-transplant and PT-CY at 50 mg/kg per day on day +3 and +4.', 'interventionNames': ['Drug: Cyclosporine']}, {'type': 'NO_INTERVENTION', 'label': 'Arm 2', 'description': 'Cyclosporine 6 mg/kg orally divided into two doses per day starting in the morning on day +5 of the transplant, mycophenolic acid 1 gram orally (2 tablets of 500 mg) from day +5 post-transplant and post-transplant cyclophosphamide (PT-CY) at 50 mg/kg per day on days +3 and +4'}], 'interventions': [{'name': 'Cyclosporine', 'type': 'DRUG', 'description': 'Cyclosporine 6 mg/kg and mycophenolic acid 1 gram orally on day 0 post-transplant', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Perla Colunga-Pedraza, MD', 'role': 'CONTACT', 'email': 'colunga.perla@gmail.com', 'phone': '+5218110761973'}], 'facility': 'Hospital Universitario Dr. José E. González, Centro Universitario contra el Cáncer', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}], 'centralContacts': [{'name': 'Perla R Colunga-Pedraza, MD', 'role': 'CONTACT', 'email': 'colunga.perla@gmail.com', 'phone': '528183488510', 'phoneExt': '378'}, {'name': 'Julia Colunga-Pedraza, MD', 'role': 'CONTACT', 'email': 'julia_ecp@hotmail.com', 'phone': '528183486136', 'phoneExt': '435'}], 'overallOfficials': [{'name': 'Oscar González-Llano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario ¨Dr. José Eleuterio González'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Dr. Jose E. Gonzalez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of service', 'investigatorFullName': 'David Gomez Almaguer', 'investigatorAffiliation': 'Hospital Universitario Dr. Jose E. Gonzalez'}}}}