Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2026-01-22 @ 8:17 AM
Study NCT ID:
NCT01933906
Status:
COMPLETED
Last Update Posted:
2019-01-04
First Post:
2013-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C417083', 'term': 'peginterferon alfa-2b'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-03', 'studyFirstSubmitDate': '2013-08-29', 'studyFirstSubmitQcDate': '2013-08-29', 'lastUpdatePostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and seriousness of adverse events to evaluate safety and tolerability', 'timeFrame': '30 months', 'description': 'The primary objective is to determine the safety and tolerability of the addition of P1101 to the pre-study established dose of imatinib.'}], 'secondaryOutcomes': [{'measure': 'Efficacy (Number of patients achieving an improvement of remission status)', 'timeFrame': '30 months', 'description': 'Secondary objective is to determine the rate of achievement of ≥ 1 log reduction from the initial BCR-ABL transcript level at study entry and the achievement of molecular remission 4.5 or undetectable BCR-ABL transcripts.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CML', 'Chronic myeloid leukemia', 'Chronic myeloid leukaemia', 'PEG-Proline-Interferon-alpha 2b', 'Interferon', 'P1101', 'Imatinib'], 'conditions': ['Chronic Phase Chronic Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'In this phase I pilot study, it is planned to investigate the feasibility and safety of adding an interferon therapy to an preexisting imatinib treatment in patients with chronic phase chronic myeloid leukaemia. The participating patients have already reached a response during their imatinib therapy (CCyR) but have still a detectable disease (no molecular response MR 4.5 or better).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years of age\n* BCR-ABL positive chronic myeloid leukaemia in chronic phase treated with imatinib as first line therapy\n* CHR, CCyR after at least 18 months of imatinib treatment\n* Adequate organ function, defined as the following:\n\n * total bilirubin \\< 1.5 x ULN,\n * AST and ALT \\< 2.5 x ULN,\n * creatinine \\< 1.5 x ULN,\n * ANC \\> 1.5 x 109/L,\n * platelets \\> 100 x 109/L\n* Written, voluntarily signed informed consent\n\nExclusion Criteria:\n\n* CMR (molecular remission 4.5 or BCR-ABL transcripts undetectable)\n* Patient has received any other investigational treatment within 28 days before study entry\n* Treatment with a second generation tyrosine kinase inhibitor (dasatinib, nilotinib)\n* ECOG performance status ≥ 3\n* Patients with a primary of a different histological origin than the study indication (unless relapse-free interval is ≥ 5 years, except cervical carcinoma, basal cell epithelioma or squamous cell carcinoma of the skin)\n* Evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease etc.)\n* Acute chronic infections\n* Known autoimmune disease (e.g. collagen disease, polyarthritis, immune thrombocytopenia, thyroiditis, psoriasis, lupus nephritis or any other autoimmune disorder)\n* Female patients who are pregnant or breast-feeding\n* Known diagnosis of HIV'}, 'identificationModule': {'nctId': 'NCT01933906', 'briefTitle': 'Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response', 'organization': {'class': 'OTHER', 'fullName': 'Arbeitsgemeinschaft medikamentoese Tumortherapie'}, 'officialTitle': 'Phase 1 Study to Evaluate the Feasibility and Efficacy of the Addition of P1101 (PEG-Proline-Interferon Alpha-2b) to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response (MR 4.5 or BCR-ABL Transcripts Not Detectable)', 'orgStudyIdInfo': {'id': 'AGMT_CML 1'}, 'secondaryIdInfos': [{'id': '2013-000115-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'P1101', 'description': 'P1101 50µg s.c. will be administered every 2 weeks in addition to preexisting imatinib treatment. In the absence of dose limiting toxicities after 12 weeks, the dose will be escalated to 100µg every 2 weeks.\n\nMaximum treatment duration will not expand 18 months.', 'interventionNames': ['Drug: P1101']}], 'interventions': [{'name': 'P1101', 'type': 'DRUG', 'otherNames': ['PEG-Proline-Interferon alpha-2b'], 'armGroupLabels': ['P1101']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4600', 'city': 'Wels', 'state': 'Upper Austria', 'country': 'Austria', 'facility': 'Klinikum Wels-Grieskirchen GmbH, IV. Interne Abteilung', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}, {'zip': 'A-6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Universitätskliniken Innsbruck, Univ.-Klinik f.Innere Medizin V Hämtologie u. Onkologie', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': 'A-4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Ordensklinikum Linz - Elisabethinen', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Universitätsklinikum der PMU Salzburg, Universitätsklinik für Innere Medizin III', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}], 'overallOfficials': [{'name': 'Josef Thaler, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Klinikum Wels-Grieskirchen GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arbeitsgemeinschaft medikamentoese Tumortherapie', 'class': 'OTHER'}, 'collaborators': [{'name': 'AOP Orphan Pharmaceuticals AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}