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 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT06034561
Eligibility Criteria:
Inclusion Criteria:
* Patients between 16 and 60 years-old with refractory or relapsed ALL (≥1% of anomalous blasts by flow cytometry in bone marrow or peripheral blood) after one or two lines of therapy, regardless of their phenotype or baseline genetic alteration;
* Patients are eligible after allogeneic HSCT as long as patients are not actively being treated for graft-versus-host-disease (GvHD).
Exclusion Criteria:
* Burkitt leukemia;
* Prior myeloproliferative disease;
* Drug allergies;
* Eastern Cooperative Oncology Group (ECOG) scale \>2;
* Total bilirubin\>2x upper limit of normal (ULN);
* Transaminases\>5x ULN;
* Creatinine\>2,5 mg/dl;
* Active uncontrolled infection;
* History of asparaginase-induced pancreatitis;
* Prior exposure to bortezomib;
* Heart failure New York Heart Association (NYHA) Class III or IV;
* Patients with more than 400mg/m2 lifetime exposure of anthracycline;
* Severe psychiatric disorder which prevents adequate compliance;
* Refusal to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
60 Years
Study:
NCT06034561
Study Brief:
Protocol Section:
NCT06034561