RecruitingPhase 2

Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia

Brazil50 participantsStarted 2024-04-01

Plain-language 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.

Who can participate

Age range

16 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete response

Timeframe: 30 days

Trial details

NCT IDNCT06034561

SponsorInstituto do Cancer do Estado de São Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08

Contact for this trial

Graziela S Silva

551138934677 graziela.sasilva@hc.fm.usp.br

View on ClinicalTrials.gov More Acute Lymphoblastic Leukemia, in Relapse trials