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:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT00030550
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of myelodysplastic syndromes (MDS) of at least 12 weeks duration
* Refractory anemia (RA)
* RA with ringed sideroblasts
* RA with excess blasts
* Chronic myelomonocytic
* No therapy-related MDS
* No myelosclerosis or myelofibrosis occupying more than 30% of marrow space (or assessed as grade 3+ or greater)
* No transformation to acute myeloid leukemia
* No more than 20% blasts in bone marrow
* No more than 5% blasts in peripheral blood
* Patients with an erythropoietin level 100 mU/mL or less must have failed epoetin alfa treatment (i.e., at least 30,000 units of epoetin alfa weekly for at least 6 weeks)
* Transfusion-dependent (received at least 2 units of packed RBCs or whole blood within the past 8 weeks) OR
* Transfusion-independent (no packed RBC or whole blood transfusions within the past 8 weeks with 2 hemoglobin levels (at least 7 days apart) less than 11 g/dL)
* No iron deficiency (e.g., absent bone marrow iron store)
* If marrow aspirate is not evaluable, transferrin saturation must be at least 20% and ferritin at least 50 ng/mL
* No uncorrected B12 or folate deficiency
* No other contributing causes of anemia (e.g., autoimmune or hereditary hemolytic disorders or gastrointestinal blood loss)
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2 OR
* Zubrod 0-2
Life expectancy:
* At least 6 months
Hematopoietic:
* See Disease Characteristics
* Absolute neutrophil count at least 500/mm\^3
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* AST and ALT less than 2 times upper limit of normal (ULN)
* Hepatitis B surface antigen negative
* Hepatitis C negative
Renal:
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* No uncontrolled hypertension
* No clinically significant, symptomatic, unstable cardiovascular disease unrelated to MDS
Pulmonary:
* No clinically significant, symptomatic, unstable pulmonary disease unrelated to MDS
Neurologic:
* No clinically significant, symptomatic, unstable neurologic disease unrelated to MDS
* No history of epilepsy
* No sustained neurologic deficit (e.g., stroke)
* No grade 2 or greater peripheral neuropathy
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use at least 1 highly effective and 1 additional effective method of contraception for 4 weeks prior to, during, and for 4 weeks after study participation
* HIV negative
* No clinically significant, symptomatic, unstable endocrine, gastrointestinal, or genitourinary disease unrelated to MDS
* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No life-threatening or active infection requiring parenteral antibiotics
* No other serious concurrent illness
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* More than 7 days since prior hematopoietic growth factors (e.g., epoetin alfa, filgrastim (G-CSF), sargramostim (GM-CSF), or interleukin-3)
* No prior thalidomide
* No prior agents intended to inhibit vascular endothelial growth factor or tumor necrosis factor alfa (e.g., etanercept or infliximab)
* No concurrent epoetin alfa
Chemotherapy:
* No concurrent chemotherapy that may be active against MDS
Endocrine therapy:
* More than 30 days since prior androgens
* No requirement for ongoing therapy with systemic corticosteroids
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* More than 30 days since prior treatment for MDS except RBC transfusion or epoetin alfa
* More than 30 days since prior participation in another experimental clinical trial
* More than 30 days since prior experimental drugs
* No other concurrent investigational agents or treatments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00030550
Study Brief:
Protocol Section:
NCT00030550