Actively Recruiting
Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia
Led by Instituto do Cancer do Estado de São Paulo · Updated on 2025-05-16
50
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
Sponsors
I
Instituto do Cancer do Estado de São Paulo
Lead Sponsor
L
Libbs Farmacêutica LTDA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 16 to 60 years with refractory or relapsed acute lymphoblastic leukemia after one or two prior therapies
- Patients with at least 1% abnormal blasts detected by flow cytometry in bone marrow or blood
- Patients eligible after allogeneic stem-cell transplant if not currently treated for graft-versus-host disease
You will not qualify if you...
- Diagnosis of Burkitt leukemia
- History of myeloproliferative disease
- Known drug allergies
- Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
- Total bilirubin levels more than twice the upper limit of normal
- Liver transaminase levels more than five times the upper limit of normal
- Creatinine levels greater than 2.5 mg/dl
- Active uncontrolled infections
- History of pancreatitis caused by asparaginase
- Prior treatment with bortezomib
- Heart failure classified as New York Heart Association Class III or IV
- Lifetime anthracycline exposure exceeding 400 mg/m2
- Severe psychiatric disorder preventing compliance
- Refusal to participate in the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Instituto do Cancer do Estado de Sao Paulo
São Paulo, São Paulo, Brazil, 01246000
Actively Recruiting
Research Team
G
Graziela S Silva
CONTACT
B
Bruna Moraes, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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