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New treatment option for Acute Lymphoblastic Leukemia, in Relapse
Official title Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT06034561
What this study is testing
What is Bortezomib?
Bortezomib is an investigational medicine, being studied as a potential treatment for acute lymphoblastic leukemia, in relapse.
Also referred to as Vincristine, Doxorubicin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 60
You may be able to join if
- 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)...
- Patients are eligible after allogeneic HSCT as long as patients are not actively being treated for graft-versus-host-disease (GvHD).
You likely can't join if
- 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;
See the full eligibility 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...
- Patients are eligible after allogeneic HSCT as long as patients are not actively being treated for graft-versus-host-disease (GvHD).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.