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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00043134 |
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.
PURPOSE: 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.
Condition | Intervention | Phase |
---|---|---|
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: decitabine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | 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 |
Estimated Enrollment: | 220 |
Study Start Date: | May 2002 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: 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.
Patients are followed every 2 months for 1 year and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this study within 2 years.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of primary or secondary myelodysplastic syndromes (MDS)
Bone marrow blast count on aspiration or biopsy of 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Investigator: | Pierre W. Wijermans, MD, PhD | HagaZiekenhuis - Locatie Leyenburg |
Investigator: | Michael Luebbert, MD | University Hospital Freiburg |
Study ID Numbers: | CDR0000256224, EORTC-06011, SUPERGEN-EORTC-06011, GMDSG-EORTC-06011, EudraCT-2005-002830 |
Study First Received: | August 5, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00043134 |
Health Authority: | Unspecified |
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 myelodysplastic/myeloproliferative disease, unclassifiable |
Myelodysplastic syndromes Chronic myelogenous leukemia Precancerous Conditions Chronic myelomonocytic leukemia Refractory anemia Hematologic Diseases Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Myelodysplasia Myelodysplastic Syndromes Myeloproliferative Disorders Anemia |
Decitabine Leukemia, Myeloid Myelodysplastic myeloproliferative disease Leukemia Preleukemia Anemia, Refractory Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasm Metastasis Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Myelodysplastic-Myeloproliferative Diseases |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Pathologic Processes Disease Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Syndrome Enzyme Inhibitors Pharmacologic Actions |