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NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00476541
Recruitment Status : Completed
First Posted : May 22, 2007
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Study Description
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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.


Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Gemtuzumab ozogamicin Phase 3

Detailed Description:

The overall objective is to improve the cure rate of pediatric patients with newly diagnosed acute myeloid leukemia (AML). The specific aims are as follows:

1.1 Therapeutic aims

To improve the event-free survival (EFS) of AML patients who undergo risk-adapted therapy.

To improve the overall survival (OS) by reserving stem cell transplantation (SCT) to high-risk patients based on cytogenetics and response to induction therapy.

To compare the outcome of SCT using HLA-matched sibling donor (MSD) or HLA-matched unrelated donor (MUD).

To assess the efficacy and toxicity of Gemtuzumab ozogamicin (GO, Mylotarg) as post consolidation therapy.

1.2 Biologic aims

To study minimal residual disease (MRD) levels in blood and bone marrow (BM) at defined time points and to study the prognostic impact of MRD.

To test in vitro cellular drug resistance at diagnosis and relapse, and correlate these data to background factors and clinical outcome.

To secure storage of biological material from diagnosis for future biologic studies

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia
Study Start Date : January 2004
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Gemtuzumab 5 mg / m2 two courses with three week interval
 Drug: Gemtuzumab ozogamicin
Two courses of Gemtuzumab vs. no further therapy
Other Name: Mylotarg
No Intervention: 2
No further therapy


Outcome Measures
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Primary Outcome Measures :
  1. Event free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   1 Day to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476541


Locations
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Denmark
Department of Pediatrics, Aarhus University Hospital Skejby
Aarhus, Denmark, 8200
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
University of Aarhus
Investigators
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Study Chair: Henrik Hasle, MD Department of Pediatrics, Aarhus University Hospital Skejby, Aarhus, Denmark
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00476541    
Other Study ID Numbers: NOPHO-AML 2004
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2015
Keywords provided by University of Aarhus:
AML
Children
Gemtuzumab ozogamicin
Stem cell transplantation
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Gemtuzumab
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunotoxins
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs