Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-03-02 @ 11:05 PM
Study NCT ID:
NCT00043134
Status:
UNKNOWN
Last Update Posted:
2010-04-13
First Post:
2002-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-Dose Decitabine Compared With Standard Supportive Care in Treating Older Patients With Myelodysplastic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D015477', 'term': 'Leukemia, Myelomonocytic, Chronic'}, {'id': 'D000753', 'term': 'Anemia, Refractory'}, {'id': 'D000754', 'term': 'Anemia, Refractory, with Excess of Blasts'}, {'id': 'D054438', 'term': 'Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000740', 'term': 'Anemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077209', 'term': 'Decitabine'}], 'ancestors': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'lastUpdateSubmitDate': '2010-04-10', 'studyFirstSubmitDate': '2002-08-05', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of overall survival'}], 'secondaryOutcomes': [{'measure': 'Best response rate as measured by Cheson response criteria'}, {'measure': 'Overall progression-free survival'}, {'measure': 'Toxicity as assessed by CTC v2.0'}, {'measure': 'Quality of life as assessed by EORTC QLQ30'}, {'measure': 'Days in Hospital'}]}, 'conditionsModule': {'keywords': ['chronic myelomonocytic leukemia', 'de novo myelodysplastic syndromes', 'previously treated myelodysplastic syndromes', 'refractory anemia', 'refractory anemia with excess blasts', 'refractory anemia with excess blasts in transformation', 'refractory anemia with ringed sideroblasts', 'refractory cytopenia with multilineage dysplasia', 'secondary myelodysplastic syndromes', 'atypical chronic myeloid leukemia, BCR-ABL negative', 'myelodysplastic/myeloproliferative neoplasm, unclassifiable'], 'conditions': ['Leukemia', 'Myelodysplastic Syndromes', 'Myelodysplastic/Myeloproliferative Neoplasms']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'WijerMans P, Suciu S, Baila L, et al.: Low dose decitabine versus best supportive sare in elderly patients with intermediate or high risk MDS not eligible for intensive chemotherapy: final results of the randomizedpPhase III study (06011) of the EORTC Leukemia and German MDS Study Groups. [Abstract] Blood 112 (11): A-226, 2008.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Decitabine may help myelodysplasia cells develop into normal stem cells. It is not yet known if decitabine is more effective than standard supportive care in treating myelodysplastic syndrome.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of low-dose decitabine with that of standard supportive care in treating older patients who have myelodysplastic syndrome.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the efficacy of low-dose decitabine vs standard supportive care, in terms of overall survival, of elderly patients with myelodysplastic syndromes.\n* Compare the response rate and progression-free survival of patients treated with these regimens.\n* Determine the toxicity of decitabine in these patients.\n* Assess the duration of hospitalization and number of blood transfusions in patients treated with these regimens.\n* Assess the quality of life of patients treated with these regimens.\n\nOUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to cytogenetic risk factors (good vs poor vs intermediate vs unknown), disease (primary myelodysplastic syndrome (MDS) vs secondary MDS), and participating center. Patients with a successful cytogenetic exam are also stratified according to overall International Prognostic Scoring System score (intermediate 1 vs intermediate 2 vs high risk). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive decitabine IV over 4 hours every 8 hours for 3 days. Treatment repeats every 6 weeks for 4-8 courses in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients receive standard supportive care. Quality of life is assessed at baseline, every 6 weeks during therapy, every 2 months for 1 year, and then every 3 months thereafter.\n\nPatients are followed every 2 months for 1 year and then every 3 months thereafter.\n\nPROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of primary or secondary myelodysplastic syndromes (MDS)\n\n * Any FAB or WHO criteria cellular type allowed\n* Bone marrow blast count on aspiration or biopsy of 1 of the following:\n\n * No more than 10% with poor cytogenetic risk factors (defined as any numerical or structural abnormality of chromosome 7 and/or complex abnormalities)\n * 11-20%\n * 21-30% for patients with acute myeloid leukemia (AML) secondary to MDS (i.e., refractory anemia with excess blasts in transformation by FAB classification)\n * Patients who failed the cytogenetic exam are allowed provided bone marrow blasts are at least 5% and/or 2-3 cytopenias are present\n* No rapid progression towards full-blown AML\n* No blast crisis of chronic myeloid leukemia\n* No t(8;21) alone or in combination with other abnormalities\n* Ineligible for intensive chemotherapy (e.g., cytarabine or an anthracycline)\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 60 and over\n\nPerformance status\n\n* WHO 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* See Disease Characteristics\n\nHepatic\n\n* Bilirubin less than 1.5 times upper limit of normal (ULN)\n* Hepatitis B surface antigen negative\n\nRenal\n\n* Creatinine less than 1.5 times ULN\n\nCardiovascular\n\n* No severe cardiovascular disease\n* No arrhythmias requiring chronic treatment\n* No congestive heart failure\n* No New York Heart Association class III or IV heart disease\n* No symptomatic ischemic heart disease\n\nOther\n\n* HIV negative\n* No active uncontrolled infection\n* No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix within the past 2 years\n* No prior or concurrent evidence of CNS or psychiatric disorders requiring hospitalization\n* No psychological, familial, sociological, or geographical condition that would preclude study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* More than 6 weeks since prior growth factors for primary MDS\n* No concurrent antiangiogenic drugs (e.g., thalidomide)\n* No concurrent interleukin, interferon, or anti-thymocyte globulin\n\nChemotherapy\n\n* See Disease Characteristics\n* More than 6 weeks since prior hydroxyurea for primary MDS\n* No other prior chemotherapy for MDS or AML\n* Prior chemotherapy for solid tumors or lymphoma (resulting in secondary MDS) allowed\n\nEndocrine therapy\n\n* No concurrent steroids (except as inhalation therapy)\n\nRadiotherapy\n\n* Prior radiotherapy for solid tumors or lymphoma (resulting in secondary MDS) allowed\n\nSurgery\n\n* Not specified\n\nOther\n\n* More than 6 weeks since prior immunosuppressive agents for primary MDS\n* No concurrent amifostine\n* No concurrent cyclosporine\n* No other concurrent experimental therapies'}, 'identificationModule': {'nctId': 'NCT00043134', 'briefTitle': 'Low-Dose Decitabine Compared With Standard Supportive Care in Treating Older Patients With Myelodysplastic Syndrome', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Intravenous Low-Dose Decitabine Versus Supportive Care in Elderly Patients With Primary Myelodysplastic Syndrome (MDS) (>10% Blasts or High-Risk Cytogenetics), Secondary MDS or Chronic Myelomonocytic Leukemia (CMML) Who Are Not Eligible for Intensive Therapy: An EORTC-German MDS Study Group Randomized Phase III Study', 'orgStudyIdInfo': {'id': 'CDR0000256224'}, 'secondaryIdInfos': [{'id': 'EORTC-06011'}, {'id': 'SUPERGEN-EORTC-06011'}, {'id': 'GMDSG-EORTC-06011'}, {'id': 'EudraCT-2005-002830'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'decitabine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Innsbruck Universitaetsklinik', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': 'A-5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'St. Johanns-Spital', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '8800', 'city': 'Roeselare', 'country': 'Belgium', 'facility': 'H. Hartziekenhuis - Roeselaere.', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'zip': 'B-4800', 'city': 'Verviers', 'country': 'Belgium', 'facility': 'Centre Hospitalier Peltzer-La Tourelle', 'geoPoint': {'lat': 50.58907, 'lon': 5.86241}}, {'zip': '41000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'University Hospital Rebro', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '128 08', 'city': 'Prague', 'country': 'Czechia', 'facility': 'First Medical Clinic of Charles University Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '128 20', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Institute of Hematology and Blood Transfusion', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': 'D-13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite University Hospital - Campus Virchow Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'G-38114', 'city': 'Braunschweig', 'country': 'Germany', 'facility': 'Staedtisches Klinikum Braunschweig', 'geoPoint': {'lat': 52.26594, 'lon': 10.52673}}, {'zip': '28239', 'city': 'Bremen', 'country': 'Germany', 'facility': 'DIAKO Ev. Diakonie Krankenhaus gGmbH', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': 'D-01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitatsklinikum Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': 'D-47166', 'city': 'Duisburg', 'country': 'Germany', 'facility': 'St. Johannes Hospital - Medical Klinik II', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': 'DOH-52249', 'city': 'Eschweiler', 'country': 'Germany', 'facility': 'St. Antonius Hospital', 'geoPoint': {'lat': 50.81854, 'lon': 6.27184}}, {'zip': 'D-60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Klinikum der J.W. 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Salvatore', 'geoPoint': {'lat': 43.90921, 'lon': 12.9164}}, {'zip': '00161', 'city': 'Rome', 'country': 'Italy', 'facility': 'Istituto Regina Elena', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '1091 HA', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Onze Lieve Vrouwe Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '2300 CA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '6202 AZ', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': 'NL-6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum St. Radboud - Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '2545 CH', 'city': 'The Hague', 'country': 'Netherlands', 'facility': 'HagaZiekenhuis - Locatie Leyenburg', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Kantonsspital - Abteilung Onkologie', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ibn-i Sina Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': 'SO14 0YG', 'city': 'Southampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal South Hants Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Pierre W. Wijermans, MD, PhD', 'affiliation': 'HagaZiekenhuis - Locatie Leyenburg'}, {'name': 'Michael Luebbert, MD', 'affiliation': 'University Hospital Freiburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}}}}