NCT05959720 Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil
| NCT ID | NCT05959720 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto do Cancer do Estado de São Paulo |
| Condition | Acute Lymphoid Leukemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2023-09-05 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2023-09-05 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Wellington F Silva, MD PhD
PRINCIPAL INVESTIGATOR
Instituto do Cancer do Estado de São Paulo
Frequently Asked Questions
Who can join the NCT05959720 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 50 Years, studying Acute Lymphoid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05959720 currently recruiting?
Yes, NCT05959720 is actively recruiting participants. Contact the research team at graziela.sasilva@hc.fm.usp.br for enrollment information.
Where is the NCT05959720 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT05959720 clinical trial?
NCT05959720 is sponsored by Instituto do Cancer do Estado de São Paulo. The principal investigator is Wellington F Silva, MD PhD at Instituto do Cancer do Estado de São Paulo. The trial plans to enroll 180 participants.
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