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 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT00084695
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of malignant or non-malignant disease, including but not limited to any of the following:
* Acute myeloid leukemia or acute lymphoblastic leukemia (ALL) with resistant disease beyond first clinical remission (CR)
* ALL in first CR at high-risk because of 1 of the following factors:
* Hypoploidy
* Pseudodiploidy with translocations t(9;22), t(4;11), or t(8;14)
* Elevated WBC at diagnosis as follows:
* \> 100,000/mm\^3 for patients 6-12 months of age
* \> 50,000/mm\^3 for patients 10-20 years of age
* \> 20,000/mm\^3 for patients 21 years of age
* Burkitt's lymphoma/leukemia
* Chronic myelogenous leukemia in first chronic phase or beyond
* Juvenile myelomonocytic leukemia
* Advanced stage or relapsed lymphoma
* Advanced stage or relapsed solid tumors, including any of the following:
* Neuroblastoma
* Ewing's sarcoma
* Rhabdomyosarcoma
* Myelodysplastic syndromes, excluding patients with grade 3 or 4 myelofibrosis
* Familial erythrophagocytic histiocytosis
* Histiocytosis unresponsive to medical management
* Inborn errors of metabolism
* Langerhans cell histiocytosis unresponsive to medical management
* Immune deficiencies, including:
* Severe combined immune deficiency
* Wiskott-Aldrich
* Hemoglobinopathies, including sickle cell disease and thalassemia
* Severe aplastic anemia
* Fanconi's anemia
* Metabolic storage diseases
* Unrelated cord blood donor must be HLA-identical OR may be mismatched for 1, 2, or 3 HLA-loci (A, B, DR)
* No other existing HLA-identical related donor available at the time of transplantation
PATIENT CHARACTERISTICS:
Age
* 21 and under
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* Not specified
Renal
* Not specified
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
Maximum Age:
21 Years
Study:
NCT00084695
Study Brief:
Protocol Section:
NCT00084695