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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07443592
Eligibility Criteria:
Inclusion Criteria:
* De novo ALL.
* Age 18-65 years.
* No prior treatment, except:
Urgent leukapheresis, Urgent treatment of hyperleukocytosis with hydroxyurea, Urgent cranial irradiation (one dose) for CNS leukostasis, Urgent mediastinal irradiation for superior vena cava syndrome.
* Adequate general condition (ECOG score 0-2), or \>2 if due to ALL.
* Negative pregnancy test for women of childbearing age.
Exclusion Criteria:
* Age \> 65 years.
* ALL type L3 or with mature B phenotype (sIg+) or with the cytogenetic alterations characteristic of mature B-cell ALL (t(8;14), t(2;8), t(8;22)).
* Ph-positive B-cell ALL (BCR::ABL1).
* Lymphoid blast crisis of chronic myeloid leukemia.
* Patients with a history of coronary artery disease, valvular heart disease, or hypertensive heart disease, which contraindicates the use of anthracyclines.
* Patients with active chronic liver disease.
* Patients with severe chronic respiratory failure.
* Renal insufficiency not due to ALL.
* Severe neurological disorders, not due to ALL, that contraindicate the use of these treatments (especially blinatumomab).
* History of clinically significant pancreatitis, at the investigator's discretion (taking into account the date of the pancreatitis, its previous severity, and sequelae).
* Pregnancy or breastfeeding.
* Psychiatric or mental illness that prevents providing informed consent for sample submission or adequately participating in the study.
* Impaired general health (ECOG scores 3 and 4) not attributable to ALL.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07443592
Study Brief:
Protocol Section:
NCT07443592