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 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT00014495
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* One of the following diagnoses:
* Pathologically confirmed acute myeloid leukemia (AML) meeting one of the following criteria:
* Newly diagnosed AML, over age 60, and not eligible for higher priority protocols
* Newly diagnosed AML and unable to receive anthracycline-containing or high-dose cytarabine-containing regimens
* AML in relapse
* AML refractory to two courses of standard induction chemotherapy or one course of high-dose cytarabine-containing induction chemotherapy
* Chronic myelogenous leukemia in accelerated phase or myeloid blast crisis
* Refractory anemia with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocytic leukemia
* More than 25% of bone marrow blasts must be CD33 positive
* Not a candidate for immediate bone marrow transplantation with a HLA-compatible donor
* No active CNS leukemia
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 2 mg/dL (unless due to leukemia or Gilbert's disease)
* Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN)
* AST no greater than 2.5 times ULN
Renal:
* Creatinine less than 2 mg/dL OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* No New York Heart Association class III or IV cardiac disease
Pulmonary:
* No pulmonary disease
Other:
* No detectable antibodies to monoclonal antibody M195
* No serious active uncontrolled infection
* No other concurrent active malignancy requiring therapy
* No other serious or life-threatening conditions that would preclude study
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 3 weeks since prior biologic therapy and recovered
Chemotherapy:
* See Disease Characteristics
* Prior hydroxyurea allowed if discontinued before study treatment
* At least 3 weeks since other prior chemotherapy and recovered
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 3 weeks since prior radiotherapy and recovered
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
120 Years
Study:
NCT00014495
Study Brief:
Protocol Section:
NCT00014495