Tests bortezomib in adults with acute lymphoblastic leukemia that returned or did not respond
Tests bortezomib, a cancer drug, in adults with relapsed or refractory acute lymphoblastic leukemia.
Plain-language title generated from the registry record
Registry title: Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia
Key facts
- Where
- São Paulo, BrazilSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 60 years old?
Source: NCT06034561, who can take part
Where in Brazil
- Instituto do Câncer do Estado de São PauloSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto do Cancer do Estado de São Paulo
- Trial code
- NCT06034561
- Record updated
- 16 May 2025
- Original description
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.Read full original descriptionShow less
Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia in Adults
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.
Inclusion: 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: Prior myeloproliferative disease; Prior exposure to bortezomib; Drug allergies; Active uncontrolled infection; History of asparaginase-induced pancreatitis; Heart failure New York Heart Association (NYHA) Class III or IV; Severe psychiatric disorder which prevents adequate compliance; Total bilirubin>2x upper limit of normal (ULN); Transaminases>5x ULN; Creatinine>2,5 mg/dl; Burkitt leukemia; Eastern Cooperative Oncology Group (ECOG) scale >2; Patients with more than 400mg/m2 lifetime exposure of anthracycline; Refusal to participate in the study.