NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia
Recruitment status was Active, not recruiting
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.
|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|
- Event free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|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)|
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476541
|Department of Pediatrics, Aarhus University Hospital Skejby|
|Aarhus, Denmark, 8200|
|Copenhagen, Denmark, 2100|
|Study Chair:||Henrik Hasle, MD||Department of Pediatrics, Aarhus University Hospital Skejby, Aarhus, Denmark|