NCT06034561 Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia
| NCT ID | NCT06034561 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Instituto do Cancer do Estado de São Paulo |
| Condition | Acute Lymphoblastic Leukemia, in Relapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2024-04-01 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Wellington Silva, MD PhD
PRINCIPAL INVESTIGATOR
Instituto do Cancer do Estado de Sao Paulo
Frequently Asked Questions
Who can join the NCT06034561 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 60 Years, studying Acute Lymphoblastic Leukemia, in Relapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06034561 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06034561 currently recruiting?
Yes, NCT06034561 is actively recruiting participants. Contact the research team at graziela.sasilva@hc.fm.usp.br for enrollment information.
Where is the NCT06034561 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06034561 clinical trial?
NCT06034561 is sponsored by Instituto do Cancer do Estado de São Paulo. The principal investigator is Wellington Silva, MD PhD at Instituto do Cancer do Estado de Sao Paulo. The trial plans to enroll 50 participants.
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