Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-03-06 @ 5:51 AM
Study NCT ID:
NCT03821727
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2019-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SCT in Ph Positive Acute Lymphoblastic Leukemia
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': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}], 'ancestors': [{'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 441}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-26', 'studyFirstSubmitDate': '2019-01-19', 'studyFirstSubmitQcDate': '2019-01-26', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Progression-free survival (PFS).', 'timeFrame': '5 years', 'description': 'as reported'}, {'measure': 'Cumulative incidence of relapse (CIR).', 'timeFrame': '5 years', 'description': 'as reported'}, {'measure': 'Non-relapse mortality (NRM).', 'timeFrame': '5 years', 'description': 'as reported'}], 'primaryOutcomes': [{'measure': 'Overall Survival (OS).', 'timeFrame': '5 years', 'description': 'as reported'}], 'secondaryOutcomes': [{'measure': 'Rate of complete cytologic remission (CR) before and after transplant.', 'timeFrame': 'Baseline and 3 months after SCT', 'description': 'As reported'}, {'measure': 'Rate of minimal residual disease (MRD).', 'timeFrame': 'Baseline and 3 months post SCT', 'description': 'As reported'}, {'measure': 'Cumulative incidence of extensive chronic graft versus host disease (cGVHD).', 'timeFrame': '5 years', 'description': 'as reported'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Philadelphia Positive Acute Lymphoblastic Leukemia', 'SCT']}, 'referencesModule': {'references': [{'pmid': '31400502', 'type': 'DERIVED', 'citation': 'Candoni A, Rambaldi A, Fanin R, Velardi A, Arcese W, Ciceri F, Lazzarotto D, Lussana F, Olivieri J, Grillo G, Parma M, Bruno B, Sora F, Bernasconi P, Saccardi R, Foa R, Sessa M, Bresciani P, Giglio F, Picardi A, Busca A, Sica S, Perruccio K, Zucchetti E, Diral E, Iori AP, Colombo AA, Tringali S, Santarone S, Irrera G, Mancini S, Zallio F, Malagola M, Albano F, Carella AM, Olivieri A, Tecchio C, Dominietto A, Vacca A, Sorasio R, Orciuolo E, Risitano AM, Leotta S, Cortelezzi A, Mammoliti S, Oldani E, Bonifazi F; GITMO. Outcome of Allogeneic Hematopoietic Stem Cell Transplantation in Adult Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia in the Era of Tyrosine Kinase Inhibitors: A Registry-Based Study of the Italian Blood and Marrow Transplantation Society (GITMO). Biol Blood Marrow Transplant. 2019 Dec;25(12):2388-2397. doi: 10.1016/j.bbmt.2019.07.037. Epub 2019 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'This study includes a registry-based, nationwide analysis to describe the clinical outcome of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who underwent an allogeneic hematopoietic stem cell transplantation (HSCT) after a Tyrosine Kinase Inhibitors (TKI)-based treatment.', 'detailedDescription': 'This was a retrospective nationwide analysis based on registry data collected by GITMO. Inclusion criteria were: 1) diagnosis of Ph+ ALL; age ≥18 years at transplant; 2) patients receiving first allogeneic HSCT from any donor (HLA-identical sibling donor (MSD), unrelated donor (UD) or alternative donor (haploidentical or cord blood) between 2005 and 2016 in a GITMO center; 3) TKI-based treatment prior to HSCT; 4) patients with available pre-transplant MRD status, as well as complete clinical data and outcome. Data were extracted from the GITMO Registry (PROMISE Registry).\n\nThe endpoints of the study were: OS, progression-free survival (PFS), cumulative incidence of relapse (CIR), non-relapse mortality (NRM), cumulative incidence of extensive chronic graft versus host disease (cGVHD), rate of minimal residual disease (MRD) negativity and the rate of complete cytologic remission (CR) before and after transplant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Data were extracted from the GITMO Registry (PROMISE Registry). All patients received a first allogeneic HSCT from any donor.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Ph+ ALL; age ≥18 years at transplant.\n* Patients receiving first allogeneic HSCT from any donor (HLA-identical sibling donor (MSD), unrelated donor (UD) or alternative donor (haploidentical or cord blood) between 2005 and 2016 in a GITMO center.\n* TKI-based treatment prior to HSCT.\n* Patients with available pre-transplant MRD status, as well as complete clinical data and outcome.\n\nExclusion Criteria:\n\n* All cases without one or more of inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT03821727', 'briefTitle': 'SCT in Ph Positive Acute Lymphoblastic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Udine, Italy'}, 'officialTitle': 'Outcome of Hematopoietic Stem Cell Transplantation in Philadelphia Positive Acute Lymphoblastic Leukemia in the Era of Tyrosine Kinase Inhibitors. A Registry-based Study of the Italian Blood and Marrow Transplantation Society (GITMO)', 'orgStudyIdInfo': {'id': 'PRN°0068937'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hematopoietic Stem Cell Transplantation', 'type': 'PROCEDURE', 'description': 'Hematopoietic Stem Cell Transplantation in Acute Leukemia Ph positive'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'GITMO Centers and GITMO CLINICAL OFFICE-AOU-IRCSS San Martino-Ge', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'facility': 'University Hospital, Udine', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}], 'overallOfficials': [{'name': 'Renato Fanin, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Udine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data were extracted from the GITMO Registry (PROMISE Registry). All patients included in the registry signed an informed consent form. The study was conducted in compliance with current national and European legislation on clinical trials, in accordance with the Helsinki Declaration and the principles of good clinical practice (GCP). This study was approved by the GITMO board and by the institutional review board of the coordinating center (Hematology-University of Udine) and from institutional review boards of all participating centers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CANDONI ANNA', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gruppo Italiano Trapianto di Midollo Osseo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Professor', 'investigatorFullName': 'CANDONI ANNA', 'investigatorAffiliation': 'University Hospital, Udine, Italy'}}}}