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 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT00045305
Eligibility Criteria:
Inclusion Criteria:
* One of the following cytologically proven myelodysplastic syndromes
* Refractory anemia (RA)
* RA with ringed sideroblasts
* RA with excess blasts
* Chronic myelomonocytic leukemia
* International Prognosis Scoring System (IPSS) score of at least 0.5 OR red cell transfusion dependence for at least 6 months (2 units per month)
* Patients with an IPSS score less than 0.5 may be eligible provided they previously had a higher IPSS score and received chemotherapy at that time
* Suitable human leukocyte antigen (HLA)-matched donor (related or unrelated) available
* No cord blood donors
* Related donors must be genotypically matched (HLA A, B and DR) at 5/6 or 6/6 loci and may be a sibling, parent, or child
* Unrelated donors must have high resolution typing done at A, B, C and DR, and must be matched at all or may have a single antigen or allele mismatch at no more than one of these loci
* Patients must have \< 20% blasts on bone marrow study within 1 month of study entry
* Age of 18 to 70 years
* Eastern Cooperative Oncology Group performance status 0-1
* Life expectancy at least 6 months
* At least 90 days since prior autologous bone marrow transplantation
* Serum erythropoietin level greater than 100 for patients who have not received a prior course of epoetin alfa
* No iron deficiency
* Iron deficiency anemia treated with iron replacement therapy allowed
* Bilirubin less than 2.0 mg/dL
* Alkaline phosphatase less than 2 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times ULN
* Creatinine less than 2.0 mg/dL OR creatinine clearance greater than 50 mL/min
* Left ventricular ejection fraction (LVEF) at least 45% by Multigated Acquisition scan (MUGA) or echocardiogram
* Carbon Monoxide Diffusing Capacity (DLCO) at least 50% of predicted (corrected for hemoglobin)
* Forced expiratory volume in 1 second (FEV\_1) at least 50% of predicted
* Recovered from prior chemotherapy
* Physically and psychologically capable of undergoing study regimen
* Able to receive 600 cGy of total body irradiation
* HIV negative
* Negative pregnancy test
Exclusion Criteria:
* Pregnant or nursing
* Having other medical condition that would reduce life expectancy
* Active ongoing infection
* Prior myeloablative or nonmyeloablative allogeneic transplantation for Myelodysplastic syndrome or acute myeloid leukemia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00045305
Study Brief:
Protocol Section:
NCT00045305