Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia
Recruiting
Phase 2
Interventional Study
Acute Lymphoblastic Leukemia, in Relapse
Acute Lymphoblastic Leukemia With Failed Remission
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 – 60
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Instituto do Cancer do Estado de São Paulo · Other
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About This Trial
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.
Trial Locations
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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 al…
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