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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT05959720
Eligibility Criteria:
Inclusion Criteria: Patients between 16 and 50 years-old with newly diagnosed ALL, negative for Philadelphia chromosome not previously treated (except for hydroxyurea, corticosteroids, or intrathecal chemotherapy) with 20% or more lymphoblasts in bone marrow or peripheral blood.
Exclusion Criteria:
* Burkitt leukemia
* Prior myeloproliferative disease
* Philadelphia chromosome positivity through whichever methodology (RT-PCR, FISH, or conventional karyotype)
* ECOG\>2 (appendix 3)
* Total bilirubin\>2x upper limit of normal (ULN)
* Transaminases\>5x ULN
* Creatinine\>2,5 mg/dl
* Positive serology for HIV or HTLV
* Heart failure NYHA Class III or IV (appendix 4)
* Severe psychiatric disorder which prevents adequate compliance
* Prior treatment with intravenous chemotherapy
* Refusal to participate in the study
* Down syndrome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
50 Years
Study:
NCT05959720
Study Brief:
Protocol Section:
NCT05959720