About this trial
This is a interventional phase II study aiming to examine the complete response rate of a bortezomib-based salvage regimen in adults with refractory or relapsed acute lymphoblastic leukemia (ALL), seeking to compare outcomes with the available literature and with our historical data on relapsed/refractory ALL.
Eligibility criteria
Qualifiers
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).
Disqualifiers
Burkitt leukemia;
Prior myeloproliferative disease;
Drug allergies;
Eastern Cooperative Oncology Group (ECOG) scale >2;
Trial design
Treatments tested in this trial
- Bortezomib
Treatment groups
Sponsors and collaborators
Instituto do Cancer do Estado de São Paulo
Lead sponsor
Libbs Farmacêutica LTDA
Collaborator