Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia

Summary

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

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.

Conditions3

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