Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-28 @ 9:42 AM
Study NCT ID:
NCT00930566
Status:
UNKNOWN
Last Update Posted:
2013-04-24
First Post:
2009-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extracorporal Photopheresis Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008730', 'term': 'Methoxsalen'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-23', 'studyFirstSubmitDate': '2009-06-29', 'studyFirstSubmitQcDate': '2009-06-29', 'lastUpdatePostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the toxicity at Day 100 (NCI/NIH Common Toxicity Criteria) of Extracorporal Photopheresis (ECP) administered for Graft-versus-host-disease (GVHD) prophylaxis and introduced early (Day 21) after an HSCT from a genoidentical donor.', 'timeFrame': 'Day 100', 'description': 'All types of toxicity will be assessed and graded according to NCI/NIH Common Toxicity Criteria'}], 'secondaryOutcomes': [{'measure': 'Efficacy: decrease in incidence of acute GVHD and chronic GVHD', 'timeFrame': 'during 2 years'}, {'measure': 'Incidence of Infection (clinically et/or bacteriologically proved)', 'timeFrame': 'during 2 years'}, {'measure': 'Documentation of chimerism [quantification of donor-type chimerism in bone marrow and/ or in peripheral blood (total blood, CD3+)]', 'timeFrame': 'during 2 years'}, {'measure': 'Transplant-related Mortality', 'timeFrame': 'at 3 months and 1 year', 'description': 'TRM at 3 months for acute GVHD and at 1 year for chronic GVHD'}, {'measure': 'Toxicity at Day 180 after HSC transplantation', 'timeFrame': 'Day 180'}, {'measure': 'Disease-free survival (DFS)', 'timeFrame': 'at 1 and 2 years'}, {'measure': 'progression-free survival (PFS)', 'timeFrame': 'at 1 and 2 years'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'at 1 and 2 years'}, {'measure': 'cumulative incidence of relapse', 'timeFrame': 'at 1 and 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Allogeneic Hematopoietic Stem Cell Transplantation', 'Extracorporeal Photopheresis'], 'conditions': ['Hematological Malignancies']}, 'descriptionModule': {'briefSummary': 'ECP will be given to the patients \\[UVAR®XTS TM Therakos system, Johnson \\& Johnson\\] according to the following schedule:\n\nStarting at day 21 after transplant, if hematologic recovery allowed it: 2 ECP per week the first 2 weeks, and 1 ECP per week during 1 month.\n\nTotal = 8 ECP after transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years and \\< or = 65 years with an hematological malignancy indicated for an allogeneic transplantation after reduced intensity conditioning :\n* due to the age : for patients between 55 and 65 years.\n* or for patients between 18 and 55 years of age presenting a risk of increased toxicity for myeloablative conditioning (cardiac, renal or pulmonary pathology)\n* CML and MPS in blastic phase achieving CR,\n* MM stage II or III, relapse after autologous transplant, achieving a response ≥ 30% or on first line if high risk,\n* NHL in 2nd CR, PR after chemotherapy or autologous transplant, chemo-sensible.\n* CLL in 2nd CR, PR after chemotherapy or autologous transplant, chemo-sensible.\n* AML in 2nd CR or in first line for high risk criteria, secondary AML. In AML, high risk criteria are defined by : LAM 7, leukocytes\\>30000/mm3, cytogenetic abnormalities: t(6,9); 11q23, 17p, 11q, 20q, 21q, -5, del(5q), -7/del7q, del 9q and inv 3q,\n* ALL in 2nd CR or in first line for high risk criteria defined by cytogenetic abnormalities: 11q23, t(9,22); t(1,19); t(4,11).\n* MDS patients without prior chemotherapy\n* HLA identical sibling donor\n* Performans status \\< or = 2\n* Patients member of a social security company\n\nExclusion Criteria:\n\n* Age \\< 18 years or \\> 65 years\n* Pregnant or lactating females\n* Known HIV positivity\n* Active infectious hepatitis, type A, B or C\n* Performance status \\> 2 according to WHO\n* Left ventricular ejection fraction \\< 40% and Alveolus-capillary diffusion \\< 50%\n* Uncontrollable hypertension with medical therapy\n* Creatinine clearance \\< 60 ml/min\n* Hypersensitivity or allergy to psoralen (methoxsalen)\n* Disease associated with a photosensitivity\n* Hypersensitivity or allergy to both heparin and citrate products\n* Contra-indication to Busulfan, Fludarabine, SAT or methotrexate\n* Hypersensitivity to ciclosporine, mycophenolate mofetil or mycophenolic acid'}, 'identificationModule': {'nctId': 'NCT00930566', 'acronym': 'ECP', 'briefTitle': 'Extracorporal Photopheresis Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Allogenic Hematopoietic Stem Cell Transplantation (HSCT) From a Genoidentical Donor After a Reduced Intensity Conditioning Transplantation (RICT) Followed by an Early Preventive Treatment (Day 21) With Extracorporal Photopheresis After Transplantation.', 'orgStudyIdInfo': {'id': '2006.409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extracorporal Photopheresis', 'interventionNames': ['Drug: methoxsalen', 'Procedure: Extracoporal Photopheresis (ECP)']}], 'interventions': [{'name': 'methoxsalen', 'type': 'DRUG', 'otherNames': ['UVADEX®'], 'description': 'UVADEX® is supplied in a 10 mL single-use vial. Each mL of solution contains 20 mcg of UVADEX®.\n\nIn the ECP process, UVADEX® will be injected directly into the Recirculation Bag of the extracorporal circuit after completion of the buffy coat collection, just prior to pressing the photoactivation button. The dose of UVADEX used to inoculate these cells will be calculated based on the treatment volume collected during the plasma/buffy coat collection process, usinge the following formula :\n\nTreatment Volume in mL x 0.017 = Dose of UVADEX® (in mLs) required for administration into the recirculation bag.\n\nAfter the cells are inoculated with UVADEX, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then reinfused back into the patient.', 'armGroupLabels': ['Extracorporal Photopheresis']}, {'name': 'Extracoporal Photopheresis (ECP)', 'type': 'PROCEDURE', 'otherNames': ['ECP kits : UVAR®XTS™'], 'description': 'In the ECP process, UVADEX® will be injected directly into the Recirculation Bag of the extracorporeal circuit after completion of the buffy coat collection, just prior to pressing the photoactivation button.\n\nAfter the cells are inoculated with UVADEX, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then reinfused back into the patient.', 'armGroupLabels': ['Extracorporal Photopheresis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Centre de Santé - Etablissement Français du Sang (EFS)', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69003', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aline Praire', 'role': 'CONTACT', 'email': 'aline.praire@chu-lyon.fr', 'phone': '+33472117396'}, {'name': 'Mauricette Michallet, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Hôpital Edouard Herriot, Service d'Hématologie", 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Mauricette Michallet, Professor', 'role': 'CONTACT', 'email': 'mauricette.michallet@chu-lyon.fr', 'phone': '+33472117402'}], 'overallOfficials': [{'name': 'Mauricette Michallet, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}, {'name': 'Olivier Hequet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Etablissement Français du Sang'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}