NCT05959720Recruiting
Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil
Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil - a Prospective Collaborative Study
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 180 (estimated)
- First submitted
- 17 Jul 2023
- Start date
- 5 Sept 2023
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- NCT number
- NCT05959720
What you commit to
- Study type: Observational
- Planned participants: 180
- From 5 Sept 2023 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior myeloproliferative disease
- Prior treatment with intravenous chemotherapy
Other illness
- Positive serology for HIV or HTLV
- Heart failure NYHA Class III or IV (appendix 4)
- Severe psychiatric disorder which prevents adequate compliance
- Down syndrome
Lab values
- Total bilirubin\>2x upper limit of normal (ULN)
- Transaminases\>5x ULN
- Creatinine\>2,5 mg/dl
Other
- Burkitt leukemia
- Philadelphia chromosome positivity through whichever methodology (RT-PCR, FISH, or conventional karyotype)
- ECOG\>2 (appendix 3)
- Refusal to participate in the study
Age in the registry: 16 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto do Câncer do Estado de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.