Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-28 @ 2:11 PM
Study NCT ID:
NCT02197650
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2018-12-04
First Post:
2014-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access Program: Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA®) in Combination With Polychemotherapy in Patients Under 55 Years Old With Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulation of Asparaginase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000708079', 'term': 'eryaspase'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'lastUpdateSubmitDate': '2018-11-30', 'studyFirstSubmitDate': '2014-05-07', 'studyFirstSubmitQcDate': '2014-07-21', 'lastUpdatePostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-23', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['ALL L-asparaginase encapsulated erythrocytes'], 'conditions': ['Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for patient unable to receive any other form of Asparaginase.', 'detailedDescription': 'Some patients can not be eligible to other clinical trials / program sponsored by Erytech Pharma but could have a benefit to be treated with GRASPA. Following discussion with French regulatory authorities, it has been suggested to propose access to GRASPA to patients unable to receive any other form of L-asparaginase and not eligible to the ongoing study or other program. This exploratory study should allow it in an "Expended Access Program" framework.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with ALL de novo or in relapse or refractory\n* Eligible to a chemotherapy treatment including L-asparaginase\n* Known contraindication and/or at risk of toxicity to other L-asparaginase formulation according to investigator opinion based on information available\n* Patient under 55 years old\n* Patient informed and consent provided (the 2 parents need to consent for children).\n\nExclusion Criteria:\n\n* Patient unable to receive GRASPA due to general or visceral conditions\n\n * Serum creatinine ≥ 2 x ULN unless related to ALL\n * ALT or AST ≥ 3 x ULN unless related to ALL\n * Active clinical pancreatitis any grade or pancreatic enzyme elevation ≥ 1.5 ULN\n * Other serious conditions according to investigator's opinion.\n* Absence of documented serological test for HIV, B and C hepatitis\n* History of grade 3 transfusional incident or any contraindication to receive blood transfusion\n* Patient under concomitant treatment likely to cause hemolysis\n* Presence of specific anti-erythrocyte antibodies preventing from getting a compatible erythrocyte concentrate for the patient.\n* Patient undergoing yellow fever vaccination.\n* Patient under phenytoin treatment.\n* Women of childbearing potential without effective contraception as well as pregnant or breast feeding women.\n* Patient already included in another clinical trial"}, 'identificationModule': {'nctId': 'NCT02197650', 'acronym': 'EAP', 'briefTitle': 'Expanded Access Program: Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA®) in Combination With Polychemotherapy in Patients Under 55 Years Old With Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulation of Asparaginase', 'organization': {'class': 'INDUSTRY', 'fullName': 'ERYtech Pharma'}, 'officialTitle': 'Expanded Access Program for a Multicentre, Open, Non Randomized Study, Evaluating Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA®) in Combination With Polychemotherapy in Patients Under 55 Years Old With Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulation of Asparaginase', 'orgStudyIdInfo': {'id': 'GRASPALL 2012-10-EAP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'suspension of erythrocytes encapsulating L-asparaginase', 'type': 'DRUG', 'otherNames': ['GRASPA®', 'eryaspase'], 'description': 'Erythrocytes encapsulating L-asparaginase'}]}, 'contactsLocationsModule': {'locations': [{'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Hôpital Jean Minjoz - Batiment MEMCP', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU Lille - Hôpital Claude-Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'IHOP', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': "Hôpital de l'Archet 2", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU Rouen - Hôpital des enfants', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Saint Etienne Hôpital Nord', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '31100', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Universitaire du Cancer', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Hôpital BRETONNEAU', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Hôpital Brabois Enfants', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Pr. Yves BERTRAND', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IHOP, Lyon'}, {'name': 'Pr. Hervé DOMBRET', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Saint Louis Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ERYtech Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}