Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil
About this study
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.
- Condition
- Acute Lymphoid Leukemia, Minimal Residual Disease, Gene Abnormality, Chemotherapeutic Toxicity
- Tested
- Prednisone, Vincristin, Daunorubicin, Peg-asparaginase, Intrathecal Suspension, Cyclophosphamide, Cytarabine, Mercaptopu...
- Sponsor
- Instituto do Cancer do Estado de São Paulo
Who can join
- Age
- 16 to 50 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 3
- Minimum age: 16 years
- Maximum age: 50 years
- Study condition: Acute Lymphoid Leukemia, Minimal Residual Disease, Gene Abnormality, Chemotherapeutic Toxicity
Exclusion 13
- 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
1 site, 1 recruiting
Instituto do Cancer do Estado de Sao Paulo
São Paulo, São Paulo, Brazil
Contact
-
Graziela Silva
551138934677 graziela.sasilva@hc.fm.usp.br
-
Bruna Moraes, MSc
551126628112 pesquisa.hematologia@hc.fm.usp.br
Potential match only. Final eligibility is determined by the study team.