Bortezomib treatment for relapsed or refractory acute lymphoblastic leukemia

Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia in Adults

This study is testing if a new treatment using bortezomib can help adults with hard-to-treat acute lymphoblastic leukemia feel better and prepare for a stem cell transplant.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 16 Years to 60 Years
• Sex: All
• Sponsor: Instituto do Cancer do Estado de São Paulo (Academic / other)
• Drugs / interventions: blinatumomab, inotuzumab, doxorubicin, fludarabine
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT06034561 on ClinicalTrials.gov

What this trial studies

This phase II interventional study aims to evaluate the complete response rate of a bortezomib-based salvage regimen in adults suffering from refractory or relapsed acute lymphoblastic leukemia (ALL). The study focuses on patients who have not responded to previous treatments and seeks to provide a potential bridge to allogeneic hematopoietic stem-cell transplantation. By comparing outcomes with existing literature and historical data, the study aims to identify effective treatment strategies for this challenging patient population. The intervention involves administering bortezomib alongside other synergistic drugs to enhance treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 16 to 60 with refractory or relapsed ALL after one or two lines of therapy.

Not a fit: Patients with Burkitt leukemia, prior myeloproliferative disease, or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve response rates and survival outcomes for patients with relapsed or refractory ALL.

How similar studies have performed: Previous studies have shown promising outcomes with similar salvage regimens, although this specific approach remains less studied in adults.

Eligibility criteria

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.

Where this trial is running

São Paulo, São Paulo

• Instituto do Cancer do Estado de Sao Paulo — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Wellington Silva, MD PhD — Instituto do Cancer do Estado de Sao Paulo
• Study coordinator: Graziela S Silva

Conditions Acute Lymphoblastic Leukemia, in Relapse; Acute Lymphoblastic Leukemia With Failed Remission; Acute lymphoblastic leukemia; Bortezomib; Salvage therapy; Bridge therapy; Response rate