Actively Recruiting
Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia in Adults
Led by Instituto do Cancer do Estado de São Paulo · Updated on 2025-05-16
50
Participants Needed
1
Research Sites
52 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 research aims to evaluate the complete response rate of a bortezomib-based salvage treatment in adults aged 16 to 60 with refractory or relapsed acute lymphoblastic leukemia (ALL). ALL is a rare blood cancer in adults with about half surviving long-term under current treatments, but those with resistant or returning disease have fewer options and worse outcomes. This study seeks to compare the results of this treatment with existing data and historical outcomes for relapsed or refractory ALL cases. Participants will receive one or two courses of a combination regimen including bortezomib, vincristine, doxorubicin, peg-asparaginase, dexamethasone, and intrathecal chemotherapy (methotrexate and dexamethasone). This treatment aims to help patients achieve remission and proceed to allogeneic hematopoietic stem-cell transplantation (HSCT). The study will also assess safety, feasibility, and rates of side effects such as febrile neutropenia, liver toxicity, neurotoxicity, and treatment-related mortality. During the study, researchers will monitor participants closely, measuring complete response within 30 days and tracking event-free survival, overall survival, and measurable residual disease (MRD) negativity over one year. They will also observe the number able to undergo HSCT after treatment. Participants will have regular evaluations including blood tests and clinical assessments to ensure safety and effectiveness are carefully followed throughout the trial period ending in 2029.
CONDITIONS
Brief Title
Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients between 16 and 60 years old with refractory or relapsed acute lymphoblastic leukemia after one or two prior treatments
- Patients may have any phenotype or baseline genetic alteration
- Patients are eligible after allogeneic hematopoietic stem-cell transplantation if not actively treated for graft-versus-host disease
You will not qualify if you...
- Diagnosis of Burkitt leukemia
- Prior myeloproliferative disease
- Known drug allergies
- Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
- Total bilirubin levels over twice the upper limit of normal
- Liver transaminases over five times the upper limit of normal
- Creatinine levels over 2.5 mg/dL
- Active uncontrolled infection
- History of pancreatitis caused by asparaginase
- Previous exposure to bortezomib
- Severe heart failure (New York Heart Association Class III or IV)
- Lifetime anthracycline exposure over 400 mg/m2
- Severe psychiatric disorders preventing compliance
- Refusal to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 30 days per course
Participants receive one or two courses of a bortezomib-based drug regimen as a salvage therapy aiming to achieve complete remission as a bridge to allogeneic hematopoietic stem-cell transplantation (HSCT).
Multiple visits during each course for drug administration on Days 1, 4, 8, 11, 15, 18, 19, 22, and intrathecal chemotherapy
Duration - Up to 1 year
Participants are monitored for treatment response, safety, and progression including evaluation of measurable residual disease and eligibility for HSCT.
Periodic visits for assessment of event-free survival, overall survival, and treatment outcomes
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
B
Bruna Moraes, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here