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Comparison of Consolidation Strategies for Pediatric Patients With Acute Myeloid Leukemia

NCT06211452 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2024-01-18

No results posted yet for this study

Summary

GATLA 8-AML´07 trial is an multicenter phase III dose-optimization trial for the treatment of acute myeloid leukemias in children and adolescents. Patients are treated with a combination of intensive chemotherapy in combination with intrathecal-injection by CNS and haematopoietic stem cell transplantation.

The patients are stratified in a standard-group (SR) and a high risk-group (HR). SR was defined as FAB (French-American-British) M1/M2 with Auer rods; FAB M4eo or favorable cytogenetics \[t(8;21)/AML1-ETO or inv(16) or t(16;16) and/or CBFB/MYH11)\]; bone marrow blasts ≤5% on day 15. HR was defined as all others. SR patients were reclassified to the HR group if FLT3-ITD positive.

Based on the experience of the BFM group, it was decided to randomly evaluate whether the six-drug conventional consolidation stage can be replaced with the use of a consolidation based by block therapy on drugs of proven efficacy in AML with the aim of reducing residual disease, and the toxicity of this stage. Patients are randomized once the double induction is completed into those who will receive the conventional consolidation phase and those who will receive consolidation with the combination of high doses cytarabine and two different anthracyclines sequentially.

Conditions

  • AML
  • Pediatric AML

Interventions

DRUG

ARM A: Active Comparator Drug

Consolidation 6-thioguanine 60 mg/m2/d, 1 to 43 po; prednisone 40 mg/m2/d, on days 1-28 orally; vincristine 1.5 mg/m2/d, days 1, 8, 15, 22; idarubicin 7 mg/m2/d, on days 1, 8, 15, 22; cytarabine 75 mg/m2/d, on days 3-6, 10-13, 17-20, 24-27, 31-34, 38-41; intrathecal cytarabine on days 1, 15, 29, 43; cyclophosphamide 500 mg/m2/d, days 29, 43.

DRUG

ARM B: Blocks Therapy Drug

Blocks AI Cytarabine 500 mg/m2 as 24 infusion infusion x 4 d; Idarubicin 7 mg/m2 on days 3 and 5; Intrathecal cytarabine on days 0 and 6. haM Cytarabine 1 g/m2 every 12 hours for 3 days; Mitoxantrone 10 mg/m2 days 4 and 5; Intrathecal cytarabine days 6 and 15.

Sponsors & Collaborators

  • Grupo Argentino de Tratamiento de la Leucemia Aguda

    lead OTHER

Principal Investigators

  • Alcyra Fynn, Dr. · Grupo Argentino de Tratamiento de la Leucemia Aguda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-01
Primary Completion
2015-03-15
Completion
2015-12-21

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06211452 on ClinicalTrials.gov