Clinical trial · Interventional
Low-Dose Decitabine Compared With Standard Supportive Care in Treating Older Patients With Myelodysplastic Syndrome
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
NCT00043134CI-TRIAL-00003358unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| decitabine | Drug | Decitabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Duration of overall survival
Secondary outcomes (5)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of primary or secondary myelodysplastic syndromes (MDS) * Any FAB or WHO criteria cellular type allowed * Bone marrow blast count on aspiration or biopsy of 1 of the following: * No more than 10% with poor cytogenetic risk factors (defined as any numerical or structural abnormality of chromosome 7 and/or complex abnormalities) * 11-20% * 21-30% for patients with acute myeloid leukemia (AML) secondary to MDS (i.e., refractory anemia with excess blasts in transformation by FAB classification) * Patients who failed the cytogenetic exam are allowed provided bone marrow blasts are at least 5% and/or 2-3 cytopenias are present * No rapid progression towards full-blown AML * No blast crisis of chronic myeloid leukemia * No t(8;21) alone or in combination with other abnormalities * Ineligible for intensive chemotherapy (e.g., cytarabine or an anthracycline) PATIENT CHARACTERISTICS: Age * 60 and over Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Bilirubin less than 1.5 times upper limit of normal (ULN) * Hepatitis B surface antigen negative Renal * Creatinine less than 1.5 times ULN Cardiovascular * No severe cardiovascular disease * No arrhythmias requiring chronic treatment * No congestive heart failure * No New York Heart Association class III or IV heart disease * No symptomatic ischemic heart disease Other * HIV negative * No active uncontrolled infection * 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 * No prior or concurrent evidence of CNS or psychiatric disorders requiring hospitalization * No psychological, familial, sociological, or geographical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy * More than 6 weeks since prior growth factors for primary MDS * No concurrent antiangiogenic drugs (e.g., thalidomide) * No concurrent interleukin, interferon, or anti-thymocyte globulin Chemotherapy * See Disease Characteristics * More than 6 weeks since prior hydroxyurea for primary MDS * No other prior chemotherapy for MDS or AML * Prior chemotherapy for solid tumors or lymphoma (resulting in secondary MDS) allowed Endocrine therapy * No concurrent steroids (except as inhalation therapy) Radiotherapy * Prior radiotherapy for solid tumors or lymphoma (resulting in secondary MDS) allowed Surgery * Not specified Other * More than 6 weeks since prior immunosuppressive agents for primary MDS * No concurrent amifostine * No concurrent cyclosporine * No other concurrent experimental therapies
References
Publications (1)
- RESULTWijerMans 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.