NCT00476541

Brief Summary

The overall objective is to improve the cure rate of children with newly diagnosed acute myeloid leukemia (AML) who undergo risk-adapted therapy. Stem cell transplantation (SCT) is reserved to high-risk patients defined by cytogenetics and response to chemotherapy. The efficacy and toxicity of Gemtuzumab ozogamicin (GO, Mylotarg) will be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2015

Enrollment Period

8 years

First QC Date

May 21, 2007

Last Update Submit

May 12, 2016

Conditions

Acute Myeloid Leukemia

Keywords

AMLChildrenGemtuzumab ozogamicinStem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • Event free survival

    5 years

Secondary Outcomes (1)

  • Overall survival

    5 years

Study Arms (2)

1

EXPERIMENTAL

Gemtuzumab 5 mg / m2 two courses with three week interval

Drug: Gemtuzumab ozogamicin

2

NO INTERVENTION

No further therapy

Interventions

Gemtuzumab ozogamicinDRUG

Two courses of Gemtuzumab vs. no further therapy

Also known as: Mylotarg
1

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • AML as defined by the diagnostic criteria,
  • Age \< 19 years at time of study entry,
  • Written informed consent

You may not qualify if:

  • Previous chemo- or radiotherapy,
  • AML secondary to previous bone marrow failure syndrome,
  • Down syndrome (DS),
  • Acute promyelocytic leukemia (APL),
  • Juvenile myelomonocytic leukemia (JMML),
  • Myelodysplastic syndrome (MDS),
  • Fanconi anemia,
  • Positive pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Pediatrics, Aarhus University Hospital Skejby

Aarhus, 8200, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (3)

  • Lie SO, Abrahamsson J, Clausen N, Forestier E, Hasle H, Hovi L, Jonmundsson G, Mellander L, Siimes MA, Yssing M, Zeller B, Gustafsson G; Nordic Society of Pediatric Hematology and Oncology (NOPHO); AML Study Group. Long-term results in children with AML: NOPHO-AML Study Group--report of three consecutive trials. Leukemia. 2005 Dec;19(12):2090-100. doi: 10.1038/sj.leu.2403962.

    PMID: 16304571BACKGROUND

  • Lie SO, Abrahamsson J, Clausen N, Forestier E, Hasle H, Hovi L, Jonmundsson G, Mellander L, Gustafsson G. Treatment stratification based on initial in vivo response in acute myeloid leukaemia in children without Down's syndrome: results of NOPHO-AML trials. Br J Haematol. 2003 Jul;122(2):217-25. doi: 10.1046/j.1365-2141.2003.04418.x.

    PMID: 12846889BACKGROUND

  • Hasle H, Abrahamsson J, Forestier E, Ha SY, Heldrup J, Jahnukainen K, Jonsson OG, Lausen B, Palle J, Zeller B; Nordic Society of Paediatric Haematology and Oncology (NOPHO). Gemtuzumab ozogamicin as postconsolidation therapy does not prevent relapse in children with AML: results from NOPHO-AML 2004. Blood. 2012 Aug 2;120(5):978-84. doi: 10.1182/blood-2012-03-416701. Epub 2012 Jun 22.

    PMID: 22730539DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Gemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CalicheamicinsAminoglycosidesGlycosidesCarbohydratesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Henrik Hasle, MD

    Department of Pediatrics, Aarhus University Hospital Skejby, Aarhus, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 22, 2007

Study Start

January 1, 2004

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

May 13, 2016

Record last verified: 2015-05

Locations

DK(2)