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 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT00528450
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Morphologic diagnosis of acute promyelocytic leukemia (APL), confirmed by one of the following:
* Demonstration of t(15;17) using conventional cytogenetics or fluorescence in situ hybridization (FISH)
* Positive PML-RARα transcript by reverse transcriptase-polymerase chain reaction (RT-PCR) assay
* Patients with CNS involvement by APL are eligible
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* Creatinine ≤ 2.0 mg/dL or creatinine clearance \> 60 mL/min
* Bilirubin \< 2.0 mg/dL (unless attributed to Gilbert disease)
* Alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)
* AST and ALT ≤ 2.5 ULN
* LVEF ≥ 50% on echocardiogram or MUGA scan
* QTc ≤ 500 msec on baseline ECG
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 4 months after the completion of study treatment
* No active serious infections not controlled by antibiotics
* No other concurrent active malignancy requiring immediate therapy
* No clinically significant cardiac disease (New York Heart Association class III or IV heart disease), including chronic arrhythmias
* No pulmonary disease
* No other serious or life-threatening condition deemed unacceptable by the principal investigator
PRIOR CONCURRENT THERAPY:
* No prior treatment for APL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00528450
Study Brief:
Protocol Section:
NCT00528450