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 @ 12:24 PM
Ignite Modification Date:
2025-12-24 @ 12:24 PM
NCT ID:
NCT00003961
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Cytologically proven myelodysplastic syndrome (MDS) of one of the following types:
* Refractory anemia with excess blasts (RAEB)
* RAEB in transformation
* Chronic myelomonocytic leukemia
* MDS with multiple chromosomal abnormalities
* MDS with life threatening cytopenias in at least 2 cell lines
* Platelet count \< 30,000/mm\^3 OR
* Absolute neutrophil count no greater than 1,000/mm\^3 OR
* Anemia requiring transfusion support
* Leukemia out of MDS (meet any of above requirements, but greater than 30% blasts in marrow)
* No acute leukemia
* Medically eligible for bone marrow transplant according to standard operating procedure of the Sidney Kimmel Cancer Center at Johns Hopkins Blood and Bone Marrow Transplant
PATIENT CHARACTERISTICS:
Age:
* 18 to 65
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No prior acute allergic reactions to sargramostim (GM-CSF)
* Not pregnant
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00003961
Study Brief:
Protocol Section:
NCT00003961