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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT00049634
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* Myelodysplastic syndromes (MDS) that has advanced beyond refractory anemia (RA)
* RA with excess blasts (RAEB) (greater than 5% blasts)
* RAEB in transformation (greater than 20% but less than 30% blasts)
* Acute myeloid leukemia (greater than 30% blasts) that evolved from MDS
* Myeloproliferative disorder, including chronic myelomonocytic leukemia, agnogenic myeloid metaplasia, polycythemia vera, or essential thrombosis
* No chronic myelogenous leukemia with or without excess (greater than 5%) blasts
* Must have an HLA-identical, related donor
PATIENT CHARACTERISTICS:
Age
* 18 to 65
Performance status
* Not specified
Life expectancy
* At least 6 months
Hematopoietic
* Not specified
Hepatic
* Bilirubin less than 2 times upper limit of normal (ULN)\*
* SGOT/SGPT less than 2 times ULN\* NOTE: \* Unless due to malignancy
Renal
* Creatinine no greater than 2.0 mg/dL OR
* Glomerular filtration rate at least 60 mL/min
Cardiovascular
* Cardiac ejection fraction at least 45%
Pulmonary
* DLCO at least 60% of predicted
Other
* HIV negative
* Human antimouse antibody negative
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other medical condition that would preclude study participation
* No hypersensitivity to cyclosporine
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior marrow transplantation
* No concurrent growth factors for 21 days after study transplantation
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:
NCT00049634
Study Brief:
Protocol Section:
NCT00049634