Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-01-01 @ 6:27 PM
Study NCT ID:
NCT06133192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Steroids Versus ECP and Steroids as First-line Treatment of Grade II Acute GVHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008730', 'term': 'Methoxsalen'}, {'id': 'D013256', 'term': 'Steroids'}], 'ancestors': [{'id': 'D011564', 'term': 'Furocoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-10', 'studyFirstSubmitDate': '2023-11-10', 'studyFirstSubmitQcDate': '2023-11-10', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from treatment failure', 'timeFrame': 'at 6 months from randomization', 'description': 'To be alive, without disease relapse, without second line treatment for acute GVHD and without systemic treatment for chronic GVHD'}], 'secondaryOutcomes': [{'measure': 'steroid cumulative dose', 'timeFrame': 'at 6 months from randomization', 'description': 'cumulative dose of steroids over time'}, {'measure': 'infections', 'timeFrame': 'at 6 months from randomization', 'description': 'incidence rate of infections (bacteremia, septicemia, fungal infections, parasite and virus'}, {'measure': 'chronic GVHD', 'timeFrame': 'at 12 months from randomization', 'description': 'incidence and severity of chronic GVHD'}, {'measure': 'non-relapse mortality', 'timeFrame': 'at 12 months from randomization', 'description': 'non-relapse mortality rate'}, {'measure': 'relapse', 'timeFrame': 'at 12 months from randomization', 'description': 'incidence of disease relapse'}, {'measure': 'overall survival', 'timeFrame': 'at 12 months from randomization', 'description': 'overall survival logrank'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Graft Vs Host Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare as a first line of grade II skin acute GVHD sconventional treatment with steroids alone to a combination of steroids and extracoporeal photopheresis (ECP)\n\nThe primary end point will compare Freedom from treatment failure at 6 months from randomization as defined by meeting all the following 4 conditions:\n\n* to be alive\n* without relapse of the hematological disease\n* without having required a new line of treatment for acute GVHD\n* without initiating a systemic treatment for chronic GVHD.', 'detailedDescription': 'A multi-center randomized phase II study comparing corticosteroids alone (standard of care) versus corticosteroids and extracorporeal photopheresis as first-line treatment of Grade II acute graft-versus-host disease with skin +/- upper gastrointestinal involvement occurring after allogeneic stem cell transplantation\n\nCorticosteroids will be started at 2 mg/kg in both arms and will be tapered once acute GVHD achieves complete remission according to strict protocol guidelines (-20% of the daily dose per week until 1 mg/kg and then 10 mg twice a day in order to stop steroids within 2 to 3 months from randomization).\n\nExtracorporeal Photopheresis (ECP) will be performed in the experimental arm : 2 sessions/week during 4 weeks then 1 session/week during 8 weeks), i.e. a total of 16 ECP sessions in 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years,\n* allogeneic hematopoietic stem cell transplantation received (from any type of graft and donor) after malignant or non malignant disease\n* patient suffering from Grade II acute GVHD with skin +/- high GI involvement (stage 2-3 skin + upper gastrointestinal tract or skin stage 3) in the 3 months following stem cell transplantation\n* patient requiring first line treatment for acute GVHD\n* patient able to start PCE therapy in the 3 days after randomization\n* validation of the presence of a peripheral or central venous access (its type should be conform to the recommendations described in the Therakos Cellex operator manual), allowing to perform PCE sessions weekly during 3 months. In the absence of appropriate preexisting central line at inclusion, peripheral access will be preferred.\n* leukocytes \\> 1.5 G/l, platelets \\> 30 G/l, hematocrit \\> 27% (blood transfusion are permitted), based on the last available blood testing results,\n* patient with French Health Insurance,\n* patient informed about the clinical trial content and organization,\n* informed consent form signed.\n\nExclusion Criteria:\n\n* \\- Grade 1 acute GVHD,\n* acute GVH grade \\> II or acute GVH with lower gastrointestinal tract or with liver involvement,\n* relapse of the hematologic disease at time of acute GVHD,\n* uncontrolled ongoing infection at time of inclusion: bacterial or fungal infections, CMV reactivation with increasing CMV viral load,\n* HIV positivity or replicative HBV or HCV infection (based on pre-transplant assessment),\n* patient with allergy or contraindications to UVADEX, extracorporeal photopheresis, steroids, or posaconazole (see details in the study protocol),\n* woman of childbearing age without efficient contraceptive method, pregnancy or breast feeding woman,\n* patient with history of profound venous thrombosis in the last 5 years,\n* patient included in another acute GVHD prospective clinical trial.'}, 'identificationModule': {'nctId': 'NCT06133192', 'acronym': 'COPAVEHDI', 'briefTitle': 'Steroids Versus ECP and Steroids as First-line Treatment of Grade II Acute GVHD', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'A Multi-center Randomized Phase II Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporeal Photopheresis as First-line Treatment of Grade II Acute Graft-versus-host Disease With Skin Involvement Occuring After Allogeneic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': '2023-508614-41-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Steroids alone', 'description': 'Steroids 2 mg/kg/day', 'interventionNames': ['Drug: Steroids']}, {'type': 'EXPERIMENTAL', 'label': 'ECP + steroids', 'description': 'Steroids 2 mg/kg abd ECP x 2 per week for 1 months and once a week for 2 months', 'interventionNames': ['Drug: Uvadex']}], 'interventions': [{'name': 'Uvadex', 'type': 'DRUG', 'description': 'Uvadex use for ECP', 'armGroupLabels': ['ECP + steroids']}, {'name': 'Steroids', 'type': 'DRUG', 'description': 'steroids 2 mg/kg/d', 'armGroupLabels': ['Steroids alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHRU de Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PU-PH', 'investigatorFullName': 'Marie-Thérèse RUBIO', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}