NCT06034561RecruitingPhase 2
Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia
Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia in Adults
Source: ClinicalTrials.gov · Last updated 16 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 6 Sept 2023
- Start date
- 1 Apr 2024
- Primary completion date
- Aug 2028
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- NCT number
- NCT06034561
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 1 Apr 2024 to the primary completion date, Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior myeloproliferative disease;
- Prior exposure to bortezomib;
Other illness
- 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;
Lab values
- Total bilirubin\>2x upper limit of normal (ULN);
- Transaminases\>5x ULN;
- Creatinine\>2,5 mg/dl;
Other
- 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.
Who the study is looking for
- 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).
Age in the registry: 16 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto do Câncer do Estado de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.