NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia - Full Text View

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:

Genetics Home Reference related topics: familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Drug Information available for: Gemtuzumab ozogamicin

U.S. FDA Resources

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:

Official website of NOPHO This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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

Hasle H, Abrahamsson J, Forestier E, Ha SY, Heldrup J, Jahnukainen K, Jónsson ÓG, 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. Epub 2012 Jun 22.

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 May 16, 2013