NCT01828489: AML2012

NOPHO-DBH AML 2012 Protocol. Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years

Status unknown Phase 3 Last updated 9 January 2017

What this trial tests

Phase 3 trial testing Randomisation course 1 mitoxantrone versus DaunoXome in Pediatric Acute Myeloblastic Leukemia in 300 participants. Status unknown.

Timeline

1 March 2013

Primary endpoint
1 March 2018

1 March 2023

Quick facts

Lead sponsor	Vastra Gotaland Region
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	1 March 2013
Primary completion	1 March 2018
Estimated completion	1 March 2023
Sites	32 locations across Belgium, Denmark, Estonia, Finland, Hong Kong, Iceland, Netherlands, Norway

Drugs / interventions tested

• Randomisation course 1 mitoxantrone versus DaunoXome — full drug profile →
• Randomisation course 2 ADxE versus FLADx — full drug profile →

Conditions studied

• Pediatric Acute Myeloblastic Leukemia — all drugs for Pediatric Acute Myeloblastic Leukemia →

Sponsor

Vastra Gotaland Region — full company profile →

Who can join

Under 18, any sex, with Pediatric Acute Myeloblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Minimal residual disease
  Time frame: On day 22 after the first induction and after second induction
  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

Sponsor's own description

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).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. MRD Tailored Therapy in AML: What We Have Learned So Far.
   Ngai LL, Kelder A, Janssen JJWM, Ossenkoppele GJ, et al · · 2020 · cited 37× · PMID 33575214 · DOI 10.3389/fonc.2020.603636
2. Risk-Stratified Therapy for Pediatric Acute Myeloid Leukemia.
   Tomizawa D, Tsujimoto SI. · · 2023 · cited 22× · PMID 37627199 · DOI 10.3390/cancers15164171
3. Measurable Residual Disease (MRD) as a Surrogate Efficacy-Response Biomarker in AML.
   Meddi E, Savi A, Moretti F, Mallegni F, et al · · 2023 · cited 12× · PMID 36834477 · DOI 10.3390/ijms24043062
4. Management of hyperleukocytosis in pediatric acute myeloid leukemia using immediate chemotherapy without leukapheresis: results from the NOPHO-DBH AML 2012 protocol.
   Zeller B, Arad-Cohen N, Cheuk D, De Moerloose B, et al · · 2024 · cited 8× · PMID 38721737 · DOI 10.3324/haematol.2024.285285
5. Associations between pretherapeutic body mass index, outcome, and cytogenetic abnormalities in pediatric acute myeloid leukemia.
   Løhmann DJA, Asdahl PH, Abrahamsson J, Ha SY, et al · · 2019 · cited 7× · PMID 31532076 · DOI 10.1002/cam4.2554
6. Effect of Antibacterial Prophylaxis on Febrile Neutropenic Episodes and Bacterial Bloodstream Infections in Dutch Pediatric Patients with Acute Myeloid Leukemia: A Two-Center Retrospective Study.
   Van Weelderen RE, Klein K, Goemans BF, Tissing WJE, et al · · 2022 · cited 6× · PMID 35804942 · DOI 10.3390/cancers14133172
7. Randomized clinical trials and informed consent in pediatric oncology: a Nordic comparative study of parents' experiences.
   Schröder Håkansson A, Andersson AC, Mellgren K, Mogensen N, et al · · 2026 · PMID 42221007 · DOI 10.3389/fped.2026.1819033