Low-Dose Decitabine Compared With Standard Supportive Care in Treating Older Patients With Myelodysplastic Syndrome

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Azacitidine; Decitabine

Criteria

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