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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT00006020
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of acute lymphocytic leukemia (ALL)
* FAB class L1-L2
* Non-T-cell ALL (lymphocytic immunophenotype markers CD19+, CD5-, and CD7- in peripheral blood, bone marrow, or in at least 1 extramedullary disease site)
* Coexpression of myeloid antigens CD13 or CD33 allowed
* Histologically confirmed extramedullary disease in the absence of bone marrow or blood involvement allowed
* CD3 and myeloperoxidase marker negative
* Meeting 1 of the following criteria for recurrent/refractory disease:
* Refractory to standard induction regimen including at least vincristine and prednisone
* Recurrence after response after prior induction therapy
* Recurrence and failure on subsequent treatment
* No CNS involvement
* Must be registered on SWOG-S9910 and SWOG-9007
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* Zubrod 0-3
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 3 times ULN
Renal:
* Creatinine no greater than 2 times ULN
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No grade 2 or greater neuropathy
* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00006020
Study Brief:
Protocol Section:
NCT00006020