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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT00492856
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Cytologically confirmed acute promyelocytic leukemia (APL) or the variant form of APL
* Previously untreated disease
* Low- or intermediate-risk disease
* Low-risk disease, defined as white blood cell (WBC) ≤ 10,000/mm\^3 and platelet count \> 40,000/mm\^3
* Intermediate-risk disease, defined as WBC ≤ 10,000/mm\^3 and platelet count ≤ 40,000/mm\^3
* WBC and platelet count confirming low- or intermediate-risk disease must be obtained within 48 hours prior to study registration unless the patient received tretinoin therapy prior to study registration in which case the WBC and platelet count must be obtained within 48 hours prior to study therapy
* PML-RARα fusion gene positive by reverse transcriptase-polymerase chain reaction (RT-PCR) assay
* No recurrent disease
* Must be registered on clinical trials SWOG-9007 and SWOG-S9910
* Specimens must be collected prior to tretinoin therapy and may be collected after tretinoin therapy
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-3
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for ≥ 1 month prior to, during, and for 2 months after completion of study treatment
* No unstable cardiac arrhythmia or unstable angina
* No other malignancy within the past 5 years except for the following:
* Adequately treated basal cell or squamous cell skin cancer
* Carcinoma in situ of the cervix
* Adequately treated stage I or II cancer (except for highly aggressive malignancies with a high rate of early relapse) currently in complete remission
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No more than 1 prior dose of intrathecal chemotherapy for acute leukemia
* No prior systemic chemotherapy, hydroxyurea, or leukapheresis for acute leukemia
* Prior tretinoin at a dose of ≤ 45 mg/m\^2/day allowed provided it was received ≤ 5 days prior to study registration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00492856
Study Brief:
Protocol Section:
NCT00492856