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 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
NCT ID:
NCT00003868
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* Acute myeloid leukemia (AML) beyond first remission OR with primary refractory disease
* AML that has transformed from myelodysplastic syndromes, if induction chemotherapy not recommended
* Documented CD45 expression in patients with relapsed disease
* Not needed for patients in remission
* Circulating blast count less than 10,000/mm\^3 (may be controlled with hydroxyurea or similar agent)
PATIENT CHARACTERISTICS:
Age
* 2 to 55
Performance status
* Not specified
Life expectancy
* More than 60 days
Hematopoietic
* See Disease Characteristics
Hepatic
* Bilirubin less than 1.5 mg/dL (unless bilirubin is determined by the gastroenterology service to be predominantly unconjugated \[indirect\] as the result of possible hemolysis)
* AST less than 1.5 times upper limit of normal (ULN)
Renal
* Creatinine less than 2.0 mg/dL OR less than 1.5 times ULN for age
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No major infection
* No circulating antibodies to mouse immunoglobulins
* HIV negative
* Able to tolerate diagnostic or therapeutic procedures (e.g., radiation isolation)
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* No radiotherapy to maximum tolerated levels to any normal organ
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
55 Years
Study:
NCT00003868
Study Brief:
Protocol Section:
NCT00003868