Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil

Recruiting now

Conditions studied: Acute Lymphoid Leukemia, Minimal Residual Disease, Gene Abnormality, Chemotherapeutic Toxicity

In brief

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.

Key facts

Study ID: NCT05959720
Run by: Instituto do Cancer do Estado de São Paulo
People needed: 180
Starts: 2023-09-05
Expected to finish: 2030-06-01
Last updated by the study team: 2025-05-07

Who can join

Age: 16 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

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

Where it is running

Instituto do Cancer do Estado de Sao Paulo — São Paulo, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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