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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT00017550
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed early myelodysplastic syndrome (MDS) with less than 10% bone marrow blasts
* Refractory anemia (RA)
* RA with excess blasts (RAEB)
* Hypocellular myelodysplasia
* Low or intermediate-1 prognostic risk
* Transfusion-dependent
* Need for 2 or more units of red blood cells or platelets per month for 2 or more months prior to study OR
* History of prior transfusions and 2 consecutive (at least 21 days apart) hemoglobin levels less than 8.0 g/dL or platelet counts less than 20,000/mm\^3 during the past 2 months
* Hemoglobin no greater than 12.0 g/dL after prior transfusion
* No myelosclerosis occupying more than 30% of bone marrow space
* No RA with ringed sideroblasts, RAEB in transformation, or chronic myelomonocytic leukemia
* No therapy-related MDS
* No history of immune-related hematologic disorder (e.g., idiopathic thrombocytopenic purpura)
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* See Disease Characteristics
* No other causes of cytopenia unrelated to MDS (e.g., gastrointestinal blood loss)
* Iron present on marrow examination OR
* Transferrin saturation at least 20% and ferritin at least 50 ng/mL
Hepatic:
* Bilirubin no greater than 2 mg/dL OR
* SGOT/SGPT no greater than 2 times normal
* No active or chronic hepatitis B or C
Renal:
* Creatinine no greater than 2 mg/dL
Cardiovascular:
* No symptomatic cardiac disease
* No congestive heart failure (even if medically controlled)
* No myocardial infarction within the past 6 months
Pulmonary:
* No severe pulmonary disease
* If history of pulmonary insufficiency, must have pO\_2 at least 90 mm/Hg on room air or pCO\_2 no greater than 40 mm/Hg
Other:
* No history of unresolved B12 or folate deficiency since diagnosis of MDS
* No untreated acute or chronic infection (afebrile for 7 days without antibiotics prior to study)
* No active or chronic HIV
* No concurrent cytomegalovirus infection
* No other malignancy within the past 2 years except adequately treated localized squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
* No concurrent drug or alcohol abuse
* No significant medical or psychosocial problems
* No known allergy to rabbit protein
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 8 weeks since prior biologic agents, colony-stimulating factors, or epoetin alfa for MDS
* At least 8 weeks since other prior investigational biologic agents
* No prior or concurrent bone marrow transplantation
* No concurrent epoetin alfa
* No concurrent growth factors except filgrastim (G-CSF) or sargramostim (GM-CSF) for neutropenic fevers
* No other concurrent biologic agents
Chemotherapy:
* At least 8 weeks since prior cytotoxic drugs for MDS
* Concurrent chemotherapy for clinical indications of disease progression or leukemic transformation allowed
Endocrine therapy:
* At least 8 weeks since prior androgenic hormonal therapy for MDS
* At least 8 weeks since prior danazol for MDS
Radiotherapy:
* No prior radiotherapy
Surgery:
* No prior organ transplantation
Other:
* At least 8 weeks since prior investigational drugs
* At least 8 weeks since prior immunosuppressive drugs or other drugs for MDS
* No concurrent immunosuppressive therapy
* No other concurrent experimental drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00017550
Study Brief:
Protocol Section:
NCT00017550