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Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil

ConditionsAcute Lymphoid LeukemiaMinimal Residual DiseaseGene AbnormalityChemotherapeutic Toxicity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-50
SponsorInstituto do Cancer do Estado de São Paulo

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Burkitt leukemia

Prior myeloproliferative disease

Philadelphia chromosome positivity through whichever methodology (RT-PCR, FISH, or conventional karyotype)

ECOG>2 (appendix 3)

Trial population

All patients from 16 years and above newly diagnosed with Philadelphia-negative ALL and after the signature of informed consent form (ICF). Patients between 16 and 17 years-old will sign a child assent along with a parental consent form. ICF application might be performed even under ALL suspicion only, given the need for sample collection before any therapy, ideally.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Prednisone

    Drug

    60 mg/m2 D1 to D21

  • Vincristin

    Drug

    1.5 mg/m2 D1, D8, D15 and D22

  • Daunorubicin

    Drug

    40 mg/m2 D1, D8, D15 and D22

  • Peg-asparaginase

    Drug

    2000 UI/m2 D12 and D26

  • Intrathecal Suspension

    Drug

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

  • Cyclophosphamide

    Drug

    1000 mg/m2 D36 and D64

  • Cytarabine

    Drug

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

  • Mercaptopurine

    Drug

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

  • Methotrexate

    Drug

    3.000 mg/m2 D8, D22, D36 and D50

  • Doxorubicin

    Drug

    30 mg/m2 D1 and D22

Treatment groups

180 Participants
are divided into 1 treatment group
Group A: Eligible patients10 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

cumulative proportion of patients alive (considering the time between the date of diagnosis and death or last follow-up)

Time frame
4 years

Secondary outcomes

1

Event-free survival (EFS)

time between enrollment in the study and the occurrence of any event: refractoriness after the first two cycles of induction, death or relapse.

Time frame
4 years
2

Early death rate

proportion of patients who died before the first bone marrow evaluation of response (after induction I)

Time frame
60 days
3

Complete response rate

proportion of patients with bone marrow aspirate with less than 5% blasts and evidence of normal hematopoiesis; CSF without blasts and recovery of peripheral blood (neutrophils≥ 1,000/μL and platelets≥100,000/μL), without the need for transfusion

Time frame
60 days
4

Cumulative incidence of relapse

rate of disease relapse after CR calculated considering death as a competing event.

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto do Cancer do Estado de São Paulo

Lead sponsor

Servier

Collaborator

Source ClinicalTrials.gov
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