Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-24 @ 12:11 AM
Study NCT ID:
NCT01335035
Status:
COMPLETED
Last Update Posted:
2012-05-01
First Post:
2011-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-Label Single-Arm Pilot Study in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019190', 'term': 'Iron Overload'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077588', 'term': 'Deferasirox'}], 'ancestors': [{'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'lastUpdateSubmitDate': '2012-04-27', 'studyFirstSubmitDate': '2011-03-30', 'studyFirstSubmitQcDate': '2011-04-12', 'lastUpdatePostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in serum ferritin', 'timeFrame': 'after 52 weeks of treatment with deferasirox'}], 'secondaryOutcomes': [{'measure': 'Mean change in the no. of sideroblasts, assessed by Perls staining', 'timeFrame': 'after 52 weeks of treatment with deferasirox'}, {'measure': 'Mean change in liver iron concentration (LIC), assessed by liver MRI.', 'timeFrame': 'after 52 weeks of treatment with deferasirox'}, {'measure': 'Incidence of chronic graft-versus-host disease ("limited" or "extensive", according to Shulman criteria)', 'timeFrame': 'up to 52 weeks of study'}, {'measure': 'Incidence of infections (bacterial, viral, or fungal)', 'timeFrame': 'up to 52 weeks of study'}, {'measure': 'Incidence of venous occlusive disease during the study', 'timeFrame': 'up to 52 weeks of study'}]}, 'conditionsModule': {'keywords': ['Iron metabolism,', 'Allogenetic Hematopoietic Stem Cell Transplant,', 'haematological diseases'], 'conditions': ['Iron Overload']}, 'referencesModule': {'references': [{'pmid': '24997153', 'type': 'DERIVED', 'citation': 'Vallejo C, Batlle M, Vazquez L, Solano C, Sampol A, Duarte R, Hernandez D, Lopez J, Rovira M, Jimenez S, Valcarcel D, Belloch V, Jimenez M, Jarque I; Subcommittee of Non-Infectious Complications of the Grupo Espanol de Trasplante Hematopoyetico (GETH). Phase IV open-label study of the efficacy and safety of deferasirox after allogeneic stem cell transplantation. Haematologica. 2014 Oct;99(10):1632-7. doi: 10.3324/haematol.2014.105908. Epub 2014 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'This study has been designed to establish the efficacy and safety of deferasirox in patients with iron overload from 6 to 18 months after allogeneic hematopoietic stem cell transplant (HSCT).\n\nThe purpose of this study is to assess the mean change in serum ferritin after 52 weeks of treatment with deferasirox, in patients with iron overload (defined with serum ferritin levels ≥ 1000 ng/ml and receiving \\> 20 RBC concentrates) after allogeneic HSCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients 18 years of age and older\n* Patients to undergo allogeneic HSCT between 6 and 18 months prior to inclusion.\n* Patients with screening ANC \\> 1000/mm3 and ferritin values ≥ 1000 ng/mL (ferritin values must be measured in two measurements at one-week intervals).\n* Patients receiving at least 20 RBC concentrate units or 100mL/kg RBC during their lives.\n* Patients giving their informed consent (prior to performing any study procedure)\n\nExclusion Criteria:\n\n* Haemosiderosis not related to transfusion.\n* Patients with concomitant active malignancy.\n* Active known viral hepatitis or known HIV-positive.\n* Mean levels of alanine aminotransferase (ALT) \\> 5x ULN\n* Treatment with any iron chelating agent after allogeneic HSCT.\n* Uncontrolled hypertension.\n\nOther protocol-defined inclusion/exclusion criteria may app'}, 'identificationModule': {'nctId': 'NCT01335035', 'briefTitle': 'Open-Label Single-Arm Pilot Study in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Open-Label Single-Arm Pilot Study of Deferasirox (Exjade®) in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload', 'orgStudyIdInfo': {'id': 'CICL670AES04'}, 'secondaryIdInfos': [{'id': 'EudraCT: 2008-003207-30', 'type': 'REGISTRY', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICL670', 'interventionNames': ['Drug: deferasirox']}], 'interventions': [{'name': 'deferasirox', 'type': 'DRUG', 'otherNames': ['ICL670'], 'armGroupLabels': ['ICL670']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Andalucia', 'country': 'Spain', 'facility': 'Novartis Investigative Site'}, {'city': 'Asturias', 'country': 'Spain', 'facility': 'Novartis Investigative Site'}, {'city': 'Canarias', 'country': 'Spain', 'facility': 'Novartis Investigative Site'}, {'city': 'Castilla Y Leon', 'country': 'Spain', 'facility': 'Novartis Investigative Site'}, {'city': 'Cataluna', 'country': 'Spain', 'facility': 'Novartis Investigative Site'}, {'city': 'Comunidad Valenciana', 'country': 'Spain', 'facility': 'Novartis Investigative Site'}, {'city': 'Islas Baleares', 'country': 'Spain', 'facility': 'Novartis Investigative Site'}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Murcia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}