Eligibility Module

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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 @ 12:40 AM
Ignite Modification Date: 2025-12-25 @ 12:40 AM
NCT ID: NCT00112567
Eligibility Criteria: DISEASE CHARACTERISTICS: * Diagnosis of a life-threatening hematologic malignancy, including any of the following: * Acute leukemia advanced beyond first remission * Acute leukemia in first remission\* with very high-risk prognostic features, including any of the following: * Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) * ALL or acute myeloid leukemia (AML) with 11q23 chromosomal abnormality * Hypodiploid ALL * Failed to achieve first remission within 1 month after induction therapy * Secondary AML * Myelodysplastic syndromes with International Prognostic Index score \> 1 * Chronic myelogenous leukemia in accelerated or blast phase NOTE: \*Must be approved by PCC * Haploidentical family donor available * No suitable HLA-matched related or unrelated donor available * No related donor mismatched for a single HLA-A, -B, -C, -DRB1, or -DQB1 antigen available PATIENT CHARACTERISTICS: Age * Under 21 Performance status * Not specified Life expectancy * At least 6 months Hematopoietic * Not specified Hepatic * SGPT and SGOT \< 2 times upper limit of normal (ULN)\* * Bilirubin \< 2 times ULN\* NOTE: \*Unless due to malignancy Renal * Not specified Cardiovascular * Ejection fraction ≥ 45% Pulmonary * DLCO ≥ 60% of predicted Other * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * No second bone marrow transplantation, after a first regimen containing total body irradiation * No concurrent growth factors until day 21 post-transplantation Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * See Biologic therapy Surgery * Not specified
Healthy Volunteers: False
Sex: ALL
Maximum Age: 20 Years
Study: NCT00112567
Study Brief:
Protocol Section: NCT00112567