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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT00003593
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Cytogenetically proven Down Syndrome (constitutional trisomy 21) with transient myeloproliferative disorder (TMD), myelodysplastic syndromes (MDS), or acute myelogenous leukemia (AML)
* Must be confirmed by bone marrow aspirate, cerebrospinal fluid exam, or blood test
* Trisomy 21 mosaicism allowed
* Group I:
* Diagnosis of TMD in patients no older than 90 days at initial presentation
* Must have nonerythroid blasts (any amount) in the peripheral blood and one of the following:
* Verification with a second sample
* More than 5% bone marrow blasts
* Hepatomegaly and/or splenomegaly
* Lymphadenopathy
* Cardiac or pleural effusions OR
* Histologically or cytologically proven TMD with blasts in an affected organ or in fluid (pericardial, pleural, or peritoneal)
* Bone marrow aspirate is required
* Group II (closed to accrual as of 6/24/04):
* Diagnosis of MDS or AML (except M3 subtype) in patients older than 90 days with more than 29% blasts in bone marrow (with or without history of TMD), or any of the following histologies:
* Refractory anemia (RA)
* RA with excess blasts (RAEB)
* RAEB in transformation
* RA with ringed sideroblasts (RARS)
* Primary cytopenia (later confirmed by bone marrow aspirate as due to marrow hypoplasia) defined by one or more of the following:
* Absolute neutrophil count less than 500/mm\^3
* Untransfused platelet count less than 30,000/mm\^3
* Untransfused hemoglobin less than 8 g/dL
* The following diagnoses will be observed only:
* RA with mild cytopenias\*
* RARS with mild cytopenias\*
* Mild primary cytopenias (one or more) without dysplasia (confirmed by hypoplastic bone marrow exam) NOTE: \* Platelet count 30-150,000/mm3, absolute neutrophil count 500-1,499/mm3, and hemoglobin greater than 8 g/dL
* Granulocytic sarcoma (chloroma), with or without bone marrow involvement, allowed
PATIENT CHARACTERISTICS:
Age:
* See Disease Characteristics
* 21 and under
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* See Disease Characteristics
Renal:
* Not specified
Cardiovascular:
* Shortening fraction greater than 27% by echocardiogram\* OR
* Ejection fraction greater than 47% by radionuclide angiogram\* NOTE: \*For patients with MDS and AML (as of 2/24/04, previously diagnosed MDS or AML closed to accrual; MDS or AML that develops (secondary to TMD) after study enrollment or MDS that requires initial observation \[with or without subsequent treatment\] allowed)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Prior chemotherapy for TMD allowed
* No prior chemotherapy for malignancy
Endocrine therapy:
* Concurrent topical or inhaled steroids for other conditions allowed
Radiotherapy:
* No prior radiotherapy for malignancy
Surgery:
* Not specified
Other:
* No prior antileukemic therapy
* Prior enrollment on this study for TMD allowed
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00003593
Study Brief:
Protocol Section:
NCT00003593