Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-31 @ 8:43 AM
Study NCT ID:
NCT01368757
Status:
UNKNOWN
Last Update Posted:
2015-03-09
First Post:
2011-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lenalidomide in Patients With Chronic Myelomonocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-04-17', 'releaseDate': '2019-01-21'}], 'estimatedResultsFirstSubmitDate': '2019-01-21'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015477', 'term': 'Leukemia, Myelomonocytic, Chronic'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'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': 'D000077269', 'term': 'Lenalidomide'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-06', 'studyFirstSubmitDate': '2011-05-09', 'studyFirstSubmitQcDate': '2011-06-07', 'lastUpdatePostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD)', 'timeFrame': '2 years', 'description': 'This is a phase I/II, open-label, dose-escalation study of lenalidomide in patients with CMML. In phase I of the study the primary purpose is to determine the MTD. The purpose of phase II is to determine the response rate.'}], 'secondaryOutcomes': [{'measure': 'Number and seriousness of adverse events to evaluate safety and tolerability', 'timeFrame': '4 years', 'description': 'For both phases (phase I and II), secondary objectives are to evaluate safety, tolerability, efficacy and analysis of molecular markers.'}, {'measure': 'Number of patients achieving transfusion independence', 'timeFrame': '4 years', 'description': 'Phase II'}, {'measure': 'Progression free survival, Overall survival', 'timeFrame': '4 years', 'description': 'Phase II'}, {'measure': 'Patients achieving cytogenetic response', 'timeFrame': '4 years', 'description': 'Phase II; Cytogenetic response assessment requires 20 analyzable metaphases using conventional cytogenetic techniques, FISH may be used an a supplement to follow a specifically defined cytogenetic abnormality'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic myelomonocytic leukemia', 'CMML', 'Lenalidomide', 'Revlimid'], 'conditions': ['Chronic Myelomonocytic Leukemia']}, 'descriptionModule': {'briefSummary': 'In a phase I study the investigators plan to investigate safety and toxicity of lenalidomide in patients with Chronic Myelomonocytic Leukemia (CMML). A phase II study will be started once an optimal dose has been found. The primary endpoint will concern the efficacy of lenalidomide in patients with CMML according to the WHO diagnostic criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. CMML according to the WHO diagnostic criteria.\n2. Understand and voluntarily sign an informed consent form.\n3. Age \\>=18 years at the time of signing the informed consent form.\n4. Able to adhere to the study visit schedule and other protocol requirements.\n5. All previous cancer therapy must have been discontinued at least 4 weeks prior to treatment in this study. Patients carrying a somatic mutation involving the platelet derived growth factor receptor beta (PDGFRB) can be included if standard treatment with imatinib failed.\n6. ECOG performance status of \\<= 2 at study entry.\n7. Laboratory test results within these ranges:\n\n * Creatinine clearance \\> 30ml/min\n * AST (SGOT) and ALT (SGPT) \\<= 2.5 x ULN\n8. Disease free of prior malignancies for \\>= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.\n9. Female subjects of childbearing potential must:\n\n * Understand the study drug is expected to have a teratogenic risk\n * Agree to use two effective contraception\n10. Male subjects must\n\n * Agree to use condoms\n * Agree not to donate semen\n11. All subjects must\n\n * Agree to abstain from donating blood\n * Agree not to share study drug with another person\n\nExclusion Criteria:\n\n1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.\n2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).\n3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.\n4. Use of any other experimental drug or therapy within 28 days of baseline.\n5. Known hypersensitivity to thalidomide.\n6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.\n7. Any prior use of lenalidomide.\n8. Concurrent use of other anti-cancer agents or treatments.\n9. Known positive for HIV or infectious hepatitis, type A, B or C.'}, 'identificationModule': {'nctId': 'NCT01368757', 'briefTitle': 'Lenalidomide in Patients With Chronic Myelomonocytic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Arbeitsgemeinschaft medikamentoese Tumortherapie'}, 'officialTitle': 'A Phase I/II Study of Lenalidomide in Patients With Chronic Myelomonocytic Leukemia', 'orgStudyIdInfo': {'id': 'AGMT_CMML 1'}, 'secondaryIdInfos': [{'id': '2009-017147-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Revlimid', 'type': 'DRUG', 'otherNames': ['lenalidomide', 'lenalidomid'], 'description': 'Dose escalation 5mg - 10mg - 15mg - 20mg in cohorts of three patients\n\nThe first step of phase I will be 5 mg lenalidomide in a daily regimen, the next step will be 10 mg in a daily regimen, the dosis of the following steps will be increased by 5 mg each until dose limiting toxicity (DLT) is reached.\n\nPhase II will be started at the MTD (1 dose step below DLT) and will be administered in a daily regimen.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'state': 'Salzburg', 'country': 'Austria', 'facility': 'Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Universitätsklinik f. Innere Medizin Graz, Klinische Abteilung f. Hämatologie', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Universitätsklinik für Innere Medizin Innsbruck, Klinische Abteilung für Hämatologie und Onkologie', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '4010', 'city': 'Linz', 'state': 'Upper Austria', 'country': 'Austria', 'facility': 'Krankenhaus d. Barmherzigen Schwestern Linz, Interne I', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '4010', 'city': 'Linz', 'state': 'Upper Austria', 'country': 'Austria', 'facility': 'Krankenhaus der Elisabethinen Linz GmbH, 1. Interne', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '4021', 'city': 'Linz', 'state': 'Upper Austria', 'country': 'Austria', 'facility': 'AKH Linz, Innere Medizin 3, Zentrum für Hämatologie und medizinische Onkologie', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'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': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'MUW/ AKH Wien Univ. Klinik für Innere Medizin I, Abteilung für Hämatologie und Hämostaseologie', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1140', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Hanusch Krankenhaus, 3. Med. Abtlg. Für Hämatologie und Onkologie', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '6807', 'city': 'Feldkirch', 'state': 'Vorarlberg', 'country': 'Austria', 'facility': 'LKH Feldkirch, Interne E', 'geoPoint': {'lat': 47.23306, 'lon': 9.6}}], 'overallOfficials': [{'name': 'Josef Thaler, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Klinikum Wels-Grieskirchen GmbH'}, {'name': 'Sonja Burgstaller, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Klinikum Wels-Grieskirchen GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arbeitsgemeinschaft medikamentoese Tumortherapie', 'class': 'OTHER'}, 'collaborators': [{'name': 'Celgene Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Prof. Dr. Richard Greil', 'oldOrganization': 'Arbeitsgemeinschaft medikamentoese Tumortherapie'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-01-21', 'type': 'RELEASE'}, {'date': '2019-04-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Arbeitsgemeinschaft medikamentoese Tumortherapie'}}}}