Contact information
Type
Scientific
Primary contact
Prof Dirk Reinhardt
ORCID ID
Contact details
Carl-Neuberg-Str. 1
Hannover
30625
Germany
reinhardt.dirk@mh-hannover.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Myeloid Leukaemia Down Syndrome 2006 for the treatment of myeloid leukaemia in children with Down syndrome: a multicentre, open-label, non-randomised trial with direct individual benefit
Acronym
ML-DS 2006
Study hypothesis
1. Standardisation of treatment for all children with Down syndrome (DS) and myeloid leukaemia (ML)
2. Achievement of an overall survival of 85% in all participating institutions
3. Optimisation of the quality of supportive therapy
4. Establishment of an international network of coordinated research in ML and DS
Ethics approval
1. Ethics committee of the University of Münster gave approval on 29th March 2007 (ref: 3VCreutzig 10)
2. Ethics committee of the Hannover Medical School gave approval on the 24th May 2007 (ref: 4378M)
Study design
Multi-centre open-label non-randomised trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Myeloid leukaemia of down syndrome
Intervention
Four elements of polychemotherapy:
Course 1:
Cytarabine 100 mg/m^2/day on days 1 and 2
Cytarabine 100 mg/m^2/12 hours on days 3 - 8
Idarubicin 8 mg/m^2/day on days 3, 5 and 7
Etoposide 150 mg/m^2/day on days 6, 7 and 8
Cytarabine intrathecal (i.th.) on day 1
Course 2:
Cytarabine 500 mg/m^2/day on days 1 - 4
Idarubicin 5 mg/m^2/day on days 3 and 5
Cytarabine intrathecal (i.th.) on day 1
Course 3:
High dose (HD) cytarabine 1 g/m^2/12 hours on days 1 - 3
Mitoxantrone 7 mg/m^2/day on days 3 and 4
Cytarabine intrathecal (i.th.) on day 1
Course 4:
High dose (HD) cytarabine 3 g/m^2/12 hours on days 1 - 3
Cytarabine intrathecal (i.th.) on day 1
In children with a body weight less than or equal to 12 kg, the dosages are calculated according to body weight. After each course, a lumbar puncture and one marrow aspiration is performed at the following points:
Course 1: day one
Course 2: day 28
Course 3: days 42 - 56
Course 4: approximately day 88
The following information is collected:
1. Online documentation of treatment elements
2. Toxicity
3. Minimal residual disease
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Event free survival
2. Overall survival
Measured at days 1, 28, 42 - 56 and 88.
Secondary outcome measures
Reduction of toxicity, measured at days 1, 28, 42 - 56 and 88.
Overall trial start date
01/01/2007
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children with trisomy 21/trisomy 21 mosaic and myeloid leukaemia
2. Aged greater than 6 months to 4 years of age with/without GATA1 mutation, or aged greater than 4 years of age to 18 years of age with GATA1 mutation, either sex
3. Patients, in the above age group, must have DS and ML
4. Written informed consent
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Children without DS
2. Children with DS and transient myeloproliferative disorder (TMD)
3. Children with DS and acute lymphoblastic leukaemia (ALL)
4. Accompanying diseases which do not allow therapy according to the protocol
5. Pre-treatment greater than 14 days with intensive induction therapy
Recruitment start date
01/01/2007
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Czech Republic, Denmark, France, Germany, Netherlands, Norway, Slovakia, Sweden
Trial participating centre
Carl-Neuberg-Str. 1
Hannover
30625
Germany
Sponsor information
Organisation
University of Münster (Germany)
Sponsor details
Domagkstr. 5
Münster
48149
Germany
ukm@uni-muenster.de
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
German Cancer Aid (Deutsche Krebshilfe) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list