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Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia

RecruitingPhase 2Ages 16 Years - 60 YearsAllInstituto do Cancer do Estado de São Paulo
NCT06034561 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Bortezomib
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Where

1 site
Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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