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

Plain Language Summary

Simplified for easier understanding

This study is testing a bortezomib-based chemotherapy combination for patients with acute lymphoblastic leukemia (ALL) — a blood cancer — that has come back or stopped responding to treatment. **You may be eligible if...** - You are between 16 and 60 years old - You have been diagnosed with relapsed or refractory ALL after one or two prior treatments - You may still be eligible even if you have had a prior bone marrow transplant, as long as you are not being treated for graft-versus-host disease **You may NOT be eligible if...** - You have Burkitt leukemia (a specific aggressive subtype) - You have significant liver, kidney, or heart problems - You have an active uncontrolled infection - You have previously been treated with bortezomib - You have a severe psychiatric condition - Your general health status is poor (ECOG above 2) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Instituto do Cancer do Estado de Sao Paulo

São Paulo, São Paulo, Brazil

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NCT06034561


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