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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT00014469
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of one of the following:
* Infant leukemia
* Acute lymphoblastic leukemia in 3rd or greater remission or relapse
* Undifferentiated or biphenotypic leukemia in 2nd or greater remission or relapse
* Juvenile chronic myelogenous leukemia (CML)
* Acute myelogenous leukemia (AML) in 3rd or greater remission or relapse
* Primary advanced myelodysplastic syndrome (MDS) excluding refractory anemia (RA) and RA with ringed sideroblasts
* Therapy-related MDS of any stage or AML
* CML in 2nd or greater chronic phase, accelerated, or blastic phase
* Acute leukemia, CML, or MDS but unable to tolerate total body irradiation (TBI) due to potential neurotoxicity (prior TBI, prior local radiotherapy,or under 2 years of age)
* No active CNS disease
* Related or unrelated bone marrow donor matched at HLA-A, B, and DR beta 1
PATIENT CHARACTERISTICS:
Age:
* Under 60 (over 60 considered on case-by-case basis)
Performance status:
* Karnofsky 70-100%
* Lansky 70-100%
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* AST and ALT less than 2 times upper limit of normal
* Bilirubin less than 1.5 mg/dL unless liver is involved with disease
Renal:
* Creatinine normal
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* Asymptomatic with no prior risk factors OR
* LVEF greater than 50% if symptomatic
Pulmonary:
* Asymptomatic with no prior risk factors OR
* Diffusion capacity greater than 50% predicted (corrected for hemoglobin) if symptomatic
Other:
* No active uncontrolled viral, bacterial, or fungal infection
* Not pregnant or nursing
* Negative pregnancy test
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* More than 6 months since prior allogeneic or autologous stem cell transplantation
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00014469
Study Brief:
Protocol Section:
NCT00014469