Treatment of adult acute lymphoblastic leukemia with a pediatric regimen in Brazil
Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil - a Prospective Collaborative Study
This study is testing a children's leukemia treatment plan to see if it can help adults in Brazil with a specific type of leukemia live longer and have fewer health problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 16 Years to 50 Years |
| Sex | All |
| Sponsor | Instituto do Cancer do Estado de São Paulo Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT05959720 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16 to 50 years with newly diagnosed Philadelphia-negative ALL and at least 20% lymphoblasts in their bone marrow or peripheral blood.
Not a fit: Patients with Philadelphia chromosome positivity or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for adults with acute lymphoblastic leukemia.
How similar studies have performed: Previous studies have shown improved outcomes with pediatric regimens in adult ALL, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
São Paulo, São Paulo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.