Actively Recruiting
Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil
Led by Instituto do Cancer do Estado de São Paulo · Updated on 2025-05-07
180
Participants Needed
1
Research Sites
351 weeks
Total Duration
On this page
Sponsors
I
Instituto do Cancer do Estado de São Paulo
Lead Sponsor
S
Servier
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this project, the investigators intend to start a prospective registry for patients with newly diagnosed Philadelphia-negative ALL from 16 years old and above in participating centers, provided that all patients will be treated with the same regimen (a pediatric regimen BFM-based incorporating peg-asparaginase). All diagnostic/follow-up (after induction and consolidation blocks) samples will be centrally biobanked at Instituto do Cancer do Estado de Sao Paulo. The main goal of this study is to examine whether the implementation of a pediatric protocol under a prospective registry can increase event-free survival (EFS) and overall survival (OS) of newly diagnosed patients in the participating centers.
CONDITIONS
Official Title
Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients between 16 and 50 years old with newly diagnosed acute lymphoblastic leukemia (ALL)
- Philadelphia chromosome negative
- Not previously treated except for hydroxyurea, corticosteroids, or intrathecal chemotherapy
- At least 20% lymphoblasts in bone marrow or peripheral blood
You will not qualify if you...
- Diagnosis of Burkitt leukemia
- Prior myeloproliferative disease
- Philadelphia chromosome positive by any test method (RT-PCR, FISH, or conventional karyotype)
- Eastern Cooperative Oncology Group (ECOG) performance status above 2
- Total bilirubin levels more than twice the upper limit of normal
- Liver transaminases more than five times the upper limit of normal
- Creatinine levels above 2.5 mg/dl
- Positive for HIV or HTLV infection
- Heart failure classified as New York Heart Association (NYHA) Class III or IV
- Severe psychiatric disorders preventing study compliance
- Prior treatment with intravenous chemotherapy
- Refusal to participate in the study
- Down syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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 Silva
CONTACT
B
Bruna Moraes, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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