Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil
Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil - a Prospective Collaborative Study
Instituto do Cancer do Estado de São Paulo
180 participants
Sep 5, 2023
OBSERVATIONAL
Conditions
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
Exclusion Criteria13
- 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
Interventions
60 mg/m2 D1 to D21
1.5 mg/m2 D1, D8, D15 and D22
40 mg/m2 D1, D8, D15 and D22
2000 UI/m2 D12 and D26
MTX 12 mg, Dexamethasone 2 mg, Cytarabine 60 mg D1, D8, D15, D22, D29
1000 mg/m2 D36 and D64
75 mg/m2 D36 to D39, D43 to D46, D50 to D53 and D57 to D60
30 mg/m2 D36 to D63 and D1 to D56 of consolidation
3.000 mg/m2 D8, D22, D36 and D50
30 mg/m2 D1 and D22
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05959720