Treatment of adult acute lymphoblastic leukemia with a pediatric regimen in Brazil

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to establish a prospective registry for patients aged 16 and older with newly diagnosed Philadelphia-negative acute lymphoblastic leukemia (ALL) in Brazil. All participants will receive a standardized pediatric BFM-based treatment regimen that includes peg-asparaginase. The study will collect diagnostic and follow-up samples for biobanking at the Instituto do Cancer do Estado de Sao Paulo, with the goal of assessing the impact of this pediatric protocol on event-free survival and overall survival rates among patients. The study addresses the need for improved treatment outcomes in adult ALL by utilizing protocols that have shown success in pediatric populations.

Why it matters

Who can join: the full rules

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

Where it's running

• Instituto do Cancer do Estado de Sao Paulo
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Wellington F Silva, MD PhD — Instituto do Cancer do Estado de São Paulo
• Study coordinator: Graziela Silva
• Email: graziela.sasilva@hc.fm.usp.br
• Phone: 551138934677

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.