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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT00016159
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of acute promyelocytic leukemia by positive RT-PCR assay for PML/RAR-alfa rearrangement or a t(15;17) karyotype
* Achieved clinical complete remission within the past 1-2 months
* Prior induction therapy must have contained tretinoin
* No other acute myeloid leukemia diagnosis
PATIENT CHARACTERISTICS:
Age:
* Any age
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin less than 2 mg/dL
* Transaminases no greater than 3 times upper limit of normal
Renal:
* Creatinine less than 2 mg/dL OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* Ejection fraction normal or greater than 50% by echocardiogram or MUGA
Other:
* No other concurrent active malignancy
* No other serious or life-threatening condition that would preclude study
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 4 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* At least 1 week since prior retinoids
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No prior postremission therapy of any form
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00016159
Study Brief:
Protocol Section:
NCT00016159