Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT01770158
Status:
TERMINATED
Last Update Posted:
2018-04-09
First Post:
2012-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maintenance Therapy With Histamine Dihydrochloride and Interleukin-2 in Adult Acute Myeloid Leukemia (AML) Patients With Measurable Minimal Residual Disease (MRD)- a Non-interventional Study (NIS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Recruitment goal cannot be achieved any more as only 8 patients have been recruited since start of the study in 2012.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-05', 'studyFirstSubmitDate': '2012-10-09', 'studyFirstSubmitQcDate': '2013-01-14', 'lastUpdatePostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of quality of life', 'timeFrame': 'two years'}], 'primaryOutcomes': [{'measure': 'leukemia-free survival / cumulative incidence of relapse', 'timeFrame': 'two years'}], 'secondaryOutcomes': [{'measure': 'Toxicity induced by the preemptive treatment with Ceplene and IL-2', 'timeFrame': '18 months', 'description': 'Duration of neutropenia and leukopenia after each treatment cycle, incidence of infections, duration of hospitalization'}, {'measure': 'Overall survival', 'timeFrame': 'two years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute myeloid leukemia (AML)', 'Histamine Dihydrochloride', 'Interleukin-2'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'This is a non-interventional multi-center study (NIS) in adult patients with AML in first complete remission with measurable minimal residual disease (MRD). Patients are eligible when gene status was already determined for previous induction and consolidation therapy of AML and showed carrier of NPM1, CBFβ-MYH11, or MLL-AF9 mutation. The study objective is to observe the impact of pre-emptive therapy with histamine dihydrochloride (HDC) and interleukin-2 (IL-2) with regard to assess leukemia-free survival/time to relapse and to monitor MRD level trend over time. HDC and IL-2 are approved drugs for AML patients in first complete remission. Therapy is administered for 10 treatment cycles as outlined in the Summary of Product Characteristics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with acute myeloid leukaemia (AML) in first remission following completion of consolidation therapy and concomitantly treated with interleukin-2 (IL-2) which will receive treatment with CEPLENE® for the first time. Patients are eligible when gene status was already determined for previous induction and consolidation therapy of AML and showed carrier of NPM1, CBFβ-MYH11, or MLL-AF9 mutation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient eligibility criteria in accordance to the summary of Product Characteristics:\n\n* Patients with confirmed diagnosis of acute myeloid leukemia according to the World Health Organization (WHO) classification (including de novo AML, t-AML and s-AML) in first complete remission (defined as less than 5% blasts in a normocellular bone marrow assessed prior to the treatment start)\n* AMLSG BiO participation incl. favourable opinion\n* Presence of NPM1 mutation, CBFB-MYH11 or MLL-AF9 fusion genes as assessed in one of the central AMLSG reference laboratories.\n* Measurable MRD values (non-negative values after consolidation therapy or increase in values over the threshold during follow-up in complete remission)\n* The patient must be informed of the observation and written informed consent regarding data privacy obtained.\n* Consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician and all other treating physicians about observation participation\n* No continuing systemic treatment with clonidine, steroids, and/or H2 receptor blocking agents.'}, 'identificationModule': {'nctId': 'NCT01770158', 'briefTitle': 'Maintenance Therapy With Histamine Dihydrochloride and Interleukin-2 in Adult Acute Myeloid Leukemia (AML) Patients With Measurable Minimal Residual Disease (MRD)- a Non-interventional Study (NIS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Maintenance Therapy With Histamine Dihydrochloride and Interleukin-2 in Adult Acute Myeloid Leukemia (AML) Patients With Measurable Minimal Residual Disease (MRD)- a Non-interventional Study (NIS)', 'orgStudyIdInfo': {'id': 'AMLSG18-12'}}, 'contactsLocationsModule': {'locations': [{'zip': '12351', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Vivantes Hospital Neukölln', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite, University Medical School of Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '64283', 'city': 'Darmstadt', 'country': 'Germany', 'facility': 'Darmstadt Clinic', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'University Hospital of Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '24939', 'city': 'Flensburg', 'country': 'Germany', 'facility': 'Malteser Krankenhaus St. Franziskus Hospital', 'geoPoint': {'lat': 54.78805, 'lon': 9.43722}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'University of Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '47674', 'city': 'Goch', 'country': 'Germany', 'facility': 'Wilhelm-Anton-Hospital gGmbH Goch', 'geoPoint': {'lat': 51.67873, 'lon': 6.15895}}, {'zip': '30449', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Klinikum Region Hannover GmbH, Krankenhaus Siloah', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '66421', 'city': 'Homburg/Saar', 'country': 'Germany', 'facility': 'Saarland University Medical Center'}, {'zip': '76133', 'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'Städtisches Klinikum Karlsruhe gGmbH', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '24116', 'city': 'Kiel', 'country': 'Germany', 'facility': 'University Medical Center Schleswig Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '66822', 'city': 'Lebach', 'country': 'Germany', 'facility': 'Caritas-Krankenhaus Lebach', 'geoPoint': {'lat': 49.41122, 'lon': 6.90988}}, {'zip': '58515', 'city': 'Lüdenscheid', 'country': 'Germany', 'facility': 'Hospital of Lüdenscheid', 'geoPoint': {'lat': 51.21977, 'lon': 7.6273}}, {'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'University Clinic Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '73557', 'city': 'Mutlangen', 'country': 'Germany', 'facility': 'Hospital of Schwäbisch Gmünd', 'geoPoint': {'lat': 48.82588, 'lon': 9.79714}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'University Hospital rechts der Isar', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '94032', 'city': 'Passau', 'country': 'Germany', 'facility': 'Hospital of Passau', 'geoPoint': {'lat': 48.5665, 'lon': 13.43122}}, {'zip': '83278', 'city': 'Traunstein', 'country': 'Germany', 'facility': 'Hospital of Traunstein', 'geoPoint': {'lat': 47.86825, 'lon': 12.64335}}, {'zip': '54290', 'city': 'Trier', 'country': 'Germany', 'facility': 'Klinikum Mutterhaus der Borromäerinnen', 'geoPoint': {'lat': 49.75565, 'lon': 6.63935}}, {'zip': '89520', 'city': 'Ulm', 'country': 'Germany', 'facility': 'University Hospital of Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '42283', 'city': 'Wuppertal', 'country': 'Germany', 'facility': 'Helios Klinikum Wuppertal', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}], 'overallOfficials': [{'name': 'Jochen Greiner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Ulm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Jochen Greiner', 'investigatorFullName': 'Jochen Greiner', 'investigatorAffiliation': 'University of Ulm'}}}}