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

50 Participants
are divided into 1 treatment group

Locations

1
Instituto do Cancer do Estado de Sao Paulo01246000, São PauloSão Paulo, Brazil

Sponsors and collaborators

Instituto do Cancer do Estado de São Paulo

Lead sponsor

Libbs Farmacêutica LTDA

Collaborator