Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil

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.

Conditions

• Acute Lymphoid Leukemia
• Minimal Residual Disease
• Gene Abnormality
• Chemotherapeutic Toxicity

Interventions

DRUG

Prednisone

60 mg/m2 D1 to D21

DRUG

Vincristin

1.5 mg/m2 D1, D8, D15 and D22

DRUG

Daunorubicin

40 mg/m2 D1, D8, D15 and D22

DRUG

Peg-asparaginase

2000 UI/m2 D12 and D26

DRUG

Intrathecal Suspension

MTX 12 mg, Dexamethasone 2 mg, Cytarabine 60 mg D1, D8, D15, D22, D29

DRUG

Cyclophosphamide

1000 mg/m2 D36 and D64

DRUG

Cytarabine

75 mg/m2 D36 to D39, D43 to D46, D50 to D53 and D57 to D60

DRUG

Mercaptopurine

30 mg/m2 D36 to D63 and D1 to D56 of consolidation

DRUG

Methotrexate

3.000 mg/m2 D8, D22, D36 and D50

DRUG

Doxorubicin

30 mg/m2 D1 and D22

Sponsors & Collaborators

• Servier

  collaborator INDUSTRY

• Instituto do Cancer do Estado de São Paulo

  lead OTHER

Principal Investigators

• Wellington F Silva, MD PhD · Instituto do Cancer do Estado de São Paulo

• Eduardo M Rego, MD PhD · Instituto do Cancer do Estado de São Paulo

Eligibility

Min Age

16 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-05

Primary Completion

2028-06-30

Completion

2030-06-30

FDA Drug

Yes

Countries

• Brazil

Study Locations