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:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT00551460
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Morphologically confirmed acute promyelocytic leukemia (APL) based on bone marrow examination
* APL-RARĪ±-negative by RT-PCR are not eligible
* High-risk disease, defined as WBC \> 100,000/mm\^3
* Bone marrow specimens must be made available for cytogenetic studies
PATIENT CHARACTERISTICS:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prolonged QTc \> 0.47 sec
* No other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or stage II cancer from which the patients is currently in complete remission
PRIOR CONCURRENT THERAPY:
* No prior systemic chemotherapy for acute leukemia
* At least 3 days since prior tretinoin (ATRA) allowed
* Prior hydroxyurea, corticosteroids, or leukapheresis to control high cell counts allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00551460
Study Brief:
Protocol Section:
NCT00551460