NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Aarhus.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00476541
First received: May 21, 2007
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
Drug: Gemtuzumab ozogamicin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Event free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: January 2004
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476541

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00476541     History of Changes
Other Study ID Numbers: NOPHO-AML 2004
Study First Received: May 21, 2007
Last Updated: March 21, 2012
Health Authority: Denmark: National Board of Health

Keywords provided by University of Aarhus:
AML
Children
Gemtuzumab ozogamicin
Stem cell transplantation

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Gemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014