Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia

Launched by INSTITUTO DO CANCER DO ESTADO DE SÃO PAULO · Sep 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment regimen that includes a medication called bortezomib for adults with acute lymphoblastic leukemia (ALL) that has either come back after treatment (relapsed) or did not respond to previous treatments (refractory). The goal of the study is to see how effective this new treatment is in helping patients achieve a complete response, meaning no signs of cancer are detectable. Researchers are looking for participants between the ages of 16 and 60 who have experienced relapsed or refractory ALL after one or two treatment attempts.

If you or a loved one are considering participation, it's important to know that eligibility includes having a specific type of leukemia and not currently being treated for certain conditions, such as complications from a previous transplant. Participants can expect close monitoring during the trial, and they will receive the bortezomib-based treatment while contributing to valuable research that may help improve future therapies for ALL. If you meet the criteria and are interested, this could be an opportunity to receive a potentially beneficial treatment while also helping advance medical knowledge.

Gender

ALL

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.