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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT01005758
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of acute lymphoblastic leukemia (ALL)
* No known mature B-cell ALL\*, defined by the presence of surface immunoglobulin, L3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8)
* Patients with T-cell surface markers and t(8;14)(q24;q11) are eligible NOTE: \*Patients with mature B-cell ALL will be removed from the study as soon as that diagnosis is made.
* No secondary ALL (i.e., ALL arising after another malignancy)
PATIENT CHARACTERISTICS:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known HIV positivity (HIV testing is not required)
* No comorbid medical condition that would, in the investigator's opinion, make participation in this study and adherence to the study guidelines a compromise to the study objectives
* No active psychiatric or mental illness that would make giving informed consent or careful clinical follow-up unlikely
PRIOR CONCURRENT THERAPY:
* No prior anti-leukemic therapy except ≤ 1 week of steroids, emergent radiotherapy to the mediastinum, hydroxyurea, or emergent leukapheresis
* Patients who have received steroids within the past 7 days are eligible but will not receive steroid prophase therapy on study
* No concurrent chronic steroids or anti-metabolite therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01005758
Study Brief:
Protocol Section:
NCT01005758