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 @ 5:22 PM
Ignite Modification Date:
2025-12-24 @ 5:22 PM
NCT ID:
NCT00089050
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspirate
* More than 20% blasts by morphologic criteria
* Relapsed disease ≥ 3 months after prior complete remission
* Blasts CD33-positive by flow cytometry
* No primary hematologic disorder that preceded initial presentation with AML
* No documented secondary AML related to prior chemotherapy or toxin exposure
* No acute promyelocytic leukemia (FAB M3)
* Not a candidate for transplant therapy
* No active CNS leukemia
PATIENT CHARACTERISTICS:
Age
* 60 and over
Performance status
* Karnofsky 70-100%
Life expectancy
* Not specified
Hematopoietic
* WBC ≤ 30,000/mm\^3 (hydroxyurea allowed)
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST or ALT ≤ 1.5 times ULN
Renal
* Creatinine ≤ 1.5 mg/dL
Other
* HIV negative
* No uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not planning hematopoietic stem cell transplantation immediately after study therapy
Chemotherapy
* See Disease Characteristics
* See Hematopoietic
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* More than 1 month since prior investigational agents
* No other concurrent anticancer therapy
* No administration of any of the following for 24 hours after cyclosporine administration:
* Diltiazem
* Verapamil
* Erythromycin
* Clarithromycin
* Metoclopramide
* Phenytoin
* Rifampin
* Phenobarbital
* Aminoglycosides
* Amphotericin B
* Vancomycin
* Cimetidine
* Ranitidine
* Trimethoprim/sulfamethoxazole
* Ketoconazole
* Fluconazole
* Itraconazole
* Voriconazole
* Carbamazepine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT00089050
Study Brief:
Protocol Section:
NCT00089050