RecruitingNot Applicable

Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil

Brazil180 participantsStarted 2023-09-05

Plain-language 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.

Who can participate

Age range16 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Overall survival (OS)

Timeframe: 4 years

Trial details

NCT IDNCT05959720

SponsorInstituto do Cancer do Estado de São Paulo

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-06

Contact for this trial

Graziela Silva

551138934677 graziela.sasilva@hc.fm.usp.br