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 @ 9:39 PM
Ignite Modification Date:
2025-12-24 @ 9:39 PM
NCT ID:
NCT00052832
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Morphologically and cytogenetically confirmed myelodysplastic syndromes or chronic myelomonocytic leukemia
* No more than 20% blasts by bone marrow biopsy
* Must meet at least 1 of the following criteria:
* Anemia
* Hemoglobin less than 11 g/dL over a 2-month period
* Thrombocytopenia
* Neutropenia
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* ALT and AST less than 1.5 times upper limit of normal
* Bilirubin less than 3 mg/dL
* Albumin greater than 3.0 g/dL
Renal
* Creatinine clearance greater than 50 mL/min
* No history of hypercalcemia
* No renal stones within the past 5 years
Cardiovascular
* No clinically significant heart failure
* No uncontrolled hypertension
Pulmonary
* No clinically significant pulmonary failure
Other
* Not pregnant
* Fertile patients must use effective contraception during and for 6 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 4 weeks since prior growth factor or cytokine therapy
Chemotherapy
* At least 8 weeks since prior cytotoxic chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* Concurrent transfusion support allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00052832
Study Brief:
Protocol Section:
NCT00052832