RecruitingPhase 2NCT06034561
Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia
Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia in Adults
Sponsor
Instituto do Cancer do Estado de São Paulo
Enrollment
50 participants
Start Date
Apr 1, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 16 YearsMax Age: 60 Years
Inclusion Criteria2
- 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 Criteria14
- 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.
Interventions
DRUGBortezomib
Patients should receive one or two courses of this regimen, aiming to achieve complete remission as a bridge to proceed with allogeneic HSCT.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06034561
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