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NCT01828489 · CITED IN SOURCE DOCUMENTS

Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
UNKNOWN
Registry last update
2017-01-10

This study evaluates the effect of different induction courses in children and adolescents with newly diagnosed acute myeloid leukemia. In the first course patients are randomised to receive either standard anthracycline therapy with mitoxantrone or experimental DaunoXome. In the second course patients are randomised between standard treatment with ADxE (cytarabine, DaunoXome, etoposide) or experimental therapy with FLADx (fludarabine, cytarabine, DaunoXome).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: 1. AML as defined by the WHO diagnostic criteria 2. Age \< 19 years at time of diagnosis 3. Written informed consent Exclusion Criteria: 1. Previous chemotherapy or radiotherapy. This includes patient with secondary AML after previous cancer therapy 2. AML secondary to previous bone marrow failure syndrome. 3. Down syndrome (DS) 4. Acute promyelocytic leukaemia (APL) 5. Myelodysplastic syndrome (MDS) 6. Juvenile Myelomonocytic Leukaemia (JMML) 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
healthy Volunteers
false
maximum Age
18 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Standard protocol arm with mitoxantrone in first course (MEC) and standard ADxE treatment in course two
    intervention Names
    1. Drug: Randomisation course 1 mitoxantrone versus DaunoXome
    2. Drug: Randomisation course 2 ADxE versus FLADx
    label
    Standard arm MEC and ADxE
    type
    ACTIVE_COMPARATOR
  2. description
    Experimental arm with DaunoXome in course one (DxEC) and standard ADxE treatment in course two
    intervention Names
    1. Drug: Randomisation course 1 mitoxantrone versus DaunoXome
    label
    Experimental DxEC and standard ADxE
    type
    EXPERIMENTAL
  3. description
    Experimental arm with standard MEC in the first course (MEC) and experimental treatment with FLADx in course two
    intervention Names
    1. Drug: Randomisation course 2 ADxE versus FLADx
    label
    Standard arm MEC and experimental FLADx
    type
    EXPERIMENTAL
  4. description
    Experimental treatment with DaunoXome in course one (DxEC) and experimental treatment with FLADx in course two
    intervention Names
    1. Drug: Randomisation course 1 mitoxantrone versus DaunoXome
    2. Drug: Randomisation course 2 ADxE versus FLADx
    label
    Experimental DxEC and experimental FLADx
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Experimental DxEC and experimental FLADx
    2. Experimental DxEC and standard ADxE
    3. Standard arm MEC and ADxE
    description
    In course one with cytarabine and etoposide either mitoxantrone (standard) or DaunoXome (experimental) is given as anthracycline.
    name
    Randomisation course 1 mitoxantrone versus DaunoXome
    type
    DRUG
  2. arm Group Labels
    1. Experimental DxEC and experimental FLADx
    2. Standard arm MEC and ADxE
    3. Standard arm MEC and experimental FLADx
    description
    The second course is randomised to either ADxE (standard arm) or FLADx
    name
    Randomisation course 2 ADxE versus FLADx
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
FACTORIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
300
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    MRD will be measured by flow cytometry. In the randomisation for course 1 the endpoint is at day 22. In the randomisation for course 2 the endpoint is immediately before start of consolidation
    measure
    Minimal residual disease
    time Frame
    On day 22 after the first induction and after second induction
secondary Outcomes
  1. description
    Event-free survival at five years
    measure
    Event-free survival
    time Frame
    5 years
  2. description
    Hematological and other organ toxicity after each course
    measure
    Acute toxicity
    time Frame
    six months
  3. description
    Long-term toxicity in particular cardiac toxicity
    measure
    Long-term toxicity
    time Frame
    10 years
  4. description
    Overall survival at five years
    measure
    Overall survival
    time Frame
    Five years
Full study description
brief Summary
This study evaluates the effect of different induction courses in children and adolescents with newly diagnosed acute myeloid leukemia. In the first course patients are randomised to receive either standard anthracycline therapy with mitoxantrone or experimental DaunoXome. In the second course patients are randomised between standard treatment with ADxE (cytarabine, DaunoXome, etoposide) or experimental therapy with FLADx (fludarabine, cytarabine, DaunoXome).
Source references
references
  1. citation
    Tierens A, Arad-Cohen N, Cheuk D, De Moerloose B, Fernandez Navarro JM, Hasle H, Jahnukainen K, Juul-Dam KL, Kaspers G, Kovalova Z, Lausen B, Noren-Nystrom U, Palle J, Pasauliene R, Jan Pronk C, Saks K, Zeller B, Abrahamsson J. Mitoxantrone Versus Liposomal Daunorubicin in Induction of Pediatric AML With Risk Stratification Based on Flow Cytometry Measurement of Residual Disease. J Clin Oncol. 2024 Jun 20;42(18):2174-2185. doi: 10.1200/JCO.23.01841. Epub 2024 Apr 11.
    pmid
    38603646
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      occurrences
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        s treatment resulted in a 70% survival rate at a median follow-up of 2.6 years.</li></ul></div></li><li>The subsequent risk-stratified <a href="/clinicaltrials/NCT01828489">NOPHO-DBH-AML2012 (NCT01828489)</a> study reported the following:[<a href="#cit/section_6.81">81</a>]<div class="pdq-content-list"><ul id="_2228"><li>The 5-ye
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      2. context exact
        rvival rate at a median follow-up of 2.6 years.</li></ul></div></li><li>The subsequent risk-stratified <a href="/clinicaltrials/NCT01828489">NOPHO-DBH-AML2012 (NCT01828489)</a> study reported the following:[<a href="#cit/section_6.81">81</a>]<div class="pdq-content-list"><ul id="_2228"><li>The 5-year EFS rate was 74.1% for patien
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      source retrieved at
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      source string sha256
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      source title
      Childhood Acute Myeloid Leukemia Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 15, 2025
        datetime
        2025-04-15T12:00:00Z
        display
        April 15, 2025

    Preserved source evidence · Not medical advice