Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia
Recruiting now · Phase 2
Conditions studied: Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphoblastic Leukemia With Failed Remission
In brief
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.
Key facts
- Study ID
- NCT06034561
- Run by
- Instituto do Cancer do Estado de São Paulo
- People needed
- 50
- Starts
- 2024-04-01
- Expected to finish
- 2029-08-01
- Last updated by the study team
- 2025-05-16
Who can join
Age: 16 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Instituto do Cancer do Estado de Sao Paulo — São Paulo, São Paulo, Brazil (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.