Research study for treatment of children and adolescents with acute myeloid leukaemia 0-18 years

Phase 1

• Conditions: Acute myeloid leukemia; MedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002934-35-NL
• Lead Sponsor: Västra Götaland Regionen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-15
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

1)AML as defined by the diagnostic criteria in the protocol
2)Age < 19 years at time of diagnosis
3)Written informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range: 700
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Previous chemotherapy or radiotherapy. This includes patient with secondary AML after previous cancer therapy. They can be treated according to the protocol but will not be included in the study population. Secondary AML has a poorer response to chemotherapy but may benefit from SCT if the procedure can be tolerated.
2)AML secondary to previous bone marrow failure syndrome.
3)Down syndrome (DS). Patients with myeloid leukaemia of Down syndrome are recommended to be treated according to the international ML-DS protocol. Patients with AML and DS older than 5 years who often lack GATA1 mutation and do not have typical myeloid leukaemia of DS may be treated according to the protocol but will not be included in the study population.
4)Acute promyelocytic leukaemia (APL). These patients are recommended treatment according to the international APL Study.
5)Myelodysplastic syndrome (MDS). These patients are recommended treatment according to EWOG-MDS.
6)Juvenile Myelomonocytic Leukaemia (JMML). These patients are recommended treatment according to EWOG-MDS.
7)Known intolerance to any of the chemotherapeutic drugs in the protocol.
8)Fanconi anaemia.
9)Major organ failure precluding administration of planned chemotherapy.
10)Positive pregnancy test .
11)Lactating female or female of childbearing potential not using adequate contraception.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified