Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT00043134
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT00043134
Study Brief:
Protocol Section:
NCT00043134