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Therapy-Optimization Trial for the Treatment of Acute Myeloid Leukemias (AML) in Children and Adolescents

NCT00111345 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2012-05-23

No results posted yet for this study

Summary

Due to progressive therapy intensification in the four consecutive studies AML-BFM 78, 83, 93 and 98, prognosis for children with acute myeloid leukemia (AML) has improved steadily. In spite of the intensified therapy, rates of morbidity and mortality have remained unchanged or have even decreased. Against the background that about 40% of the patients still die from immediate causes of an underlying disease relapse or of nonresponse, it seems to be justifiable to intensify therapy - especially for high-risk patients - which on its parts will require an optimization of supportive measures. As the present risk stratification into standard- (SR) and high-risk (HR) patients has proved effective, we will pursue the risk-adapted therapy strategy.

The aim of the study is to improve prognosis in children with AML by intensification of cytostatic therapy and to evaluate by randomisation the equivalence of a prophylactic central nervous system (CNS) irradiation with a total dose of 18 Gy versus 12 Gy.

Conditions

  • Myeloid Leukemia

Interventions

DRUG

Anthracyclines

3x12 mg/qm

DRUG

liposomal daunorubicin

3x80 mg/qm

DRUG

2-CDA

2x6 mg/qm

DRUG

AI

AI

Sponsors & Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)

    collaborator OTHER

  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Ursula Creutzig, Prof. Dr. med. · Medical School Hannover

  • Dirk Reinhardt, Prof. Dr. med. · Medical School Hanover

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2012-03-31
Completion
2017-03-31

Countries

  • Germany

Study Locations

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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 NCT00111345 on ClinicalTrials.gov