RecruitingNCT05959720

Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil

Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil - a Prospective Collaborative Study

Sponsor

Instituto do Cancer do Estado de São Paulo

Enrollment

180 participants

Start Date

Sep 5, 2023

Study Type

OBSERVATIONAL

Conditions

Chemotherapeutic Toxicity Minimal Residual Disease Gene Abnormality Acute Lymphoid Leukemia

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

Min Age: 16 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a pediatric-inspired chemotherapy regimen (a treatment protocol originally designed for children) in adults aged 16 to 50 with newly diagnosed acute lymphoblastic leukemia (ALL), a fast-growing blood cancer. Pediatric regimens have shown better results in young adults compared to traditional adult protocols. **You may be eligible if...** - You are 16 to 50 years old with a new diagnosis of ALL (Philadelphia chromosome-negative) and at least 20% lymphoblasts in your bone marrow or blood - You have not previously received IV chemotherapy for this condition **You may NOT be eligible if...** - You have Burkitt leukemia or a prior myeloproliferative (bone marrow) disease - Your ALL is Philadelphia chromosome-positive (confirmed by any method) - You have significant liver, kidney, or heart failure - You have HIV or HTLV infection - You have a severe psychiatric disorder affecting compliance - You have Down syndrome Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPrednisone

60 mg/m2 D1 to D21

DRUGVincristin

1.5 mg/m2 D1, D8, D15 and D22

DRUGDaunorubicin

40 mg/m2 D1, D8, D15 and D22

DRUGPeg-asparaginase

2000 UI/m2 D12 and D26

DRUGIntrathecal Suspension

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

DRUGCyclophosphamide

1000 mg/m2 D36 and D64

DRUGCytarabine

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

DRUGMercaptopurine

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

DRUGMethotrexate

3.000 mg/m2 D8, D22, D36 and D50

DRUGDoxorubicin

30 mg/m2 D1 and D22

Locations(1)

Instituto do Cancer do Estado de Sao Paulo

São Paulo, São Paulo, Brazil

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NCT05959720

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