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.
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).
Burkitt leukemia;
Prior myeloproliferative disease;
Drug allergies;
Eastern Cooperative Oncology Group (ECOG) scale >2;
Single group
Bortezomib
DrugPatients should receive one or two courses of this regimen, aiming to achieve complete remission as a bridge to proceed with allogeneic HSCT.
Complete response
Disappearance of lymphoid blasts in peripheral blood, with fewer than 5% of lymphoid blasts quantified in the bone marrow aspirate through immunophenotyping.
Event-free survival
Time interval between study enrollment and the occurrence of an event (non-response, relapse, or death) or last follow-up (censorship).
Overall survival
Time interval between study enrollment and the occurrence of death or last follow-up (censorship).
Rate of MRD-negativity
Absence of pathological lymphoid blasts in a bone marrow sample detected through immunophenotyping with a minimum sensitivity of 10-4.
Rate of allogeneic hematopoietic stem-cell transplantation
Proportion of patients who successfully underwent allogeneic hematopoietic stem-cell transplantation after the study therapy
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Instituto do Cancer do Estado de São Paulo
Lead sponsor
Libbs Farmacêutica LTDA
Collaborator
