This trial is active, not recruiting.

Conditions leukemia, myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasms
Treatment decitabine
Phase phase 3
Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Start date May 2002
End date May 2008
Trial size 220 participants
Trial identifier NCT00043134, CDR0000256224, EORTC-06011, EudraCT-2005-002830, GMDSG-EORTC-06011, SUPERGEN-EORTC-06011


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Masking open label
Primary purpose treatment

Primary Outcomes

Duration of overall survival
time frame:

Secondary Outcomes

Best response rate as measured by Cheson response criteria
time frame:
Overall progression-free survival
time frame:
Toxicity as assessed by CTC v2.0
time frame:
Quality of life as assessed by EORTC QLQ30
time frame:
Days in Hospital
time frame:

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

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
Description OBJECTIVES: - Compare the efficacy of low-dose decitabine vs standard supportive care, in terms of overall survival, of elderly patients with myelodysplastic syndromes. - Compare the response rate and progression-free survival of patients treated with these regimens. - Determine the toxicity of decitabine in these patients. - Assess the duration of hospitalization and number of blood transfusions in patients treated with these regimens. - Assess the quality of life of patients treated with these regimens. 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. - 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. - 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. 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2010.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).