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 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT00450450
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of hematologic cancer or other disease, including any of the following:
* Chronic myelogenous leukemia in first or second chronic phase
* Acute lymphoblastic leukemia (ALL), meeting any of the following criteria:
* Relapsed ALL enrolled on a Children's Oncology Group (COG) relapse clinical trial OR received ≥ 1 round of reinduction therapy (4-6 weeks) and 1 round of intensive consolidation chemotherapy (3-6 weeks)
* ALL in second complete remission (CR)\* after a bone marrow, extramedullary, or combined bone marrow and extramedullary relapse
* Very high-risk ALL in first CR, defined as any of the following:
* Philadelphia chromosome-positive ALL
* Hypodiploidy (\< 44 chromosomes)
* Mixed lineage leukemia rearrangement
* Induction failure
* Acute myeloid leukemia in first or second CR
* Induction therapy must be completed
* Juvenile myelomonocytic leukemia
* Myelodysplastic syndromes
* No clinically evident CNS or extramedullary disease
* No blasts seen on cerebrospinal fluid cytospin
* Post-relapse reinduction therapy must be completed
* Not planning to receive reduced-intensity conditioning regimen
* Not planning to receive a graft that has undergone T-cell depletion
* No Down syndrome
* Matched sibling donor must be available and must be enrolled on ASCT0631D companion study
* Karnofsky performance status (PS) 60-100% (patients \> 16 years of age) OR Lansky PS 60-100% (patients ≤ 16 years of age)
* AST or ALT \< 5 times upper limit of normal for age
* Bilirubin \< 2.5 mg/dL (unless due to Gilbert's syndrome)
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine base on age and/or gender as follows:
* 0.4 mg/dL (1 month to \< 6 months of age)
* 0.5 mg/dL (6 months to \< 1 year of age)
* 0.6 mg/dL (1 to 2 years of age)
* 0.8 mg/dL (2 to \< 6 years of age)
* 1.0 mg/dL (6 to \< 10 years of age)
* 1.2 mg/dL (10 to \< 13 years of age)
* 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to \< 16 years of age)
* 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
* Shortening fraction ≥ 27% by echocardiogram OR LVEF ≥ 50% by radionuclide angiogram
* FEV\_1, FVC, and DLCO ≥ 60% OR meets the following criteria (for patients unable to cooperate for pulmonary function tests):
* No evidence of dyspnea at rest
* No exercise intolerance
* No requirement for supplemental oxygen therapy
* Not pregnant or nursing
* No known HIV
* No known uncontrolled fungal, bacterial, or viral infections
* Patients acquiring fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no or minimal evidence of disease remaining by CT scan
* No prior allogeneic or autologous stem cell transplantation
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00450450
Study Brief:
Protocol Section:
NCT00450450