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 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT03668392
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent according to ICH/EU/GCP and national local laws
* Age 18 - 65 years
* Diagnosis of untreated Ph- ALL entering treatment including PEG-ASP in induction and consolidation
* ECOG performance status 0-2, unless a performance of 3 is unequivocally caused by the disease itself and not by pre-existing comorbidity, and is considered and/or documented to be reversible following the application of antileukemic therapy and appropriate supportive measures
Exclusion Criteria:
* Diagnosis of Burkitt's leukemia
* Down's syndrome
* Adults with Ph+ ALL
* Pre-existing, uncontrolled pathology such as heart failure (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrhythmias, NYHA classes III and IV)
* Severe liver disease with serum bilirubin \>3 mg/dL and/or ALT \>3 x upper normal limit (unless attributable to ALL)
* Kidney function impairment with serum creatinine \>2 mg/dL (unless attributable to ALL)
* Severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent, or to cope with the intended treatment plan
* Presence of serious, active, uncontrolled infections
* Pre-existing HIV positive serology (i.e. already known before enrolment). If HIV positivity is detected after enrolment, the patient is put off study.
* Pregnancy
* Men and women should use effective contraception during treatment and for at least 6 months after Asparaginase discontinuation. As a precautionary measure, breast-feeding should be discontinued during treatment with Asparaginase and should not be restarted after discontinuation of Asparaginase
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03668392
Study Brief:
Protocol Section:
NCT03668392