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Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil

Recruitingn/aAges 16 Years - 50 YearsAllInstituto do Cancer do Estado de São Paulo
NCT05959720 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: Patients between 16 and 50 years-old with newly diagnosed ALL, negative for Philadelphia chromosome not previously treated (except for hydroxyurea, corticosteroids, or intrathecal chemotherapy) with 20% or more lymphoblasts in bone marrow or peripheral blood. Exclusion Criteria: * Burkitt leukemia * Prior myeloproliferative disease * Philadelphia chromosome positivity through whichever methodology (RT-PCR, FISH, or conventional karyotype) * ECOG\>2 (appendix 3) * Total bilirubin\>2x upper limit of normal (ULN) * Transaminases\>5x ULN * Creatinine\>2,5 mg/dl * Positive serology for HIV or HTLV * Heart failure NYHA Class III or IV (appendix 4) * Severe psychiatric disorder which prevents adequate compliance * Prior treatment with intravenous chemotherapy * Refusal to participate in the study * Down syndrome
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What it tests

  • Prednisone
  • Vincristin
  • Daunorubicin
  • Peg-asparaginase
  • Intrathecal Suspension
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Where

1 site
Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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