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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT00005603
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of B-cell precursor acute lymphoblastic leukemia
* Registered on POG-9900 Classification Study
* Registered within 7 days of documenting complete response after induction on day 29 or, if 2 more weeks of induction are required, no later than day 49
* Classified as high risk:
* No simultaneous trisomy 4 and 10
* No TEL-AML1 gene
* Meets criteria for 1 of the following:
* Any age with WBC \> 100,000/mm\^3
* CNS and bone marrow evaluations required for those patients with WBC \> 100,000/mm\^3 who are within 24 months of initial diagnosis
* Age over 12 (boys) or 16 (girls)
* If younger, WBC must be 1 of the following:
* Greater than 80,000/mm\^3 (for boys age 8 or girls age 12)
* Greater than 60,000/mm\^3 (for boys age 9 or girls age 13)
* Greater than 40,000/mm\^3 (for boys age 10 or girls age 14)
* Greater than 20,000/mm\^3 (for boys age 11 or girls age 15)
* At least one of the following:
* CNS 3 disease (CSF WBC at least 5/microliter with blasts present)
* Testicular leukemia
* MLL gene rearrangements
PATIENT CHARACTERISTICS:
Age:
* 1 to 21
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
21 Years
Study:
NCT00005603
Study Brief:
Protocol Section:
NCT00005603