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Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil
Sponsor: Instituto do Cancer do Estado de São Paulo
Summary
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.
Official title: Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil - a Prospective Collaborative Study
Key Details
Gender
All
Age Range
16 Years - 50 Years
Study Type
OBSERVATIONAL
Enrollment
180
Start Date
2023-09-05
Completion Date
2030-06
Last Updated
2025-05-07
Healthy Volunteers
No
Interventions
Prednisone
60 mg/m2 D1 to D21
Vincristin
1.5 mg/m2 D1, D8, D15 and D22
Daunorubicin
40 mg/m2 D1, D8, D15 and D22
Peg-asparaginase
2000 UI/m2 D12 and D26
Intrathecal Suspension
MTX 12 mg, Dexamethasone 2 mg, Cytarabine 60 mg D1, D8, D15, D22, D29
Cyclophosphamide
1000 mg/m2 D36 and D64
Cytarabine
75 mg/m2 D36 to D39, D43 to D46, D50 to D53 and D57 to D60
Mercaptopurine
30 mg/m2 D36 to D63 and D1 to D56 of consolidation
Methotrexate
3.000 mg/m2 D8, D22, D36 and D50
Doxorubicin
30 mg/m2 D1 and D22
Locations (1)
Instituto do Cancer do Estado de Sao Paulo
São Paulo, São Paulo, Brazil