Myeloid Leukaemia Down Syndrome 2006 for the treatment of myeloid leukaemia in children with Down syndrome

ISRCTN ISRCTN41024033
DOI https://doi.org/10.1186/ISRCTN41024033
Secondary identifying numbers N/A
Submission date
17/02/2009
Registration date
19/03/2009
Last edited
19/03/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Dirk Reinhardt
Scientific

Carl-Neuberg-Str. 1
Hannover
30625
Germany

Email reinhardt.dirk@mh-hannover.de

Study information

Study designMulti-centre open-label non-randomised trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMyeloid 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
Study acronymML-DS 2006
Study objectives1. 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(s)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)
Health condition(s) or problem(s) studiedMyeloid leukaemia of down syndrome
InterventionFour 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 typeOther
Primary outcome measure1. Event free survival
2. Overall survival

Measured at days 1, 28, 42 - 56 and 88.
Secondary outcome measuresReduction of toxicity, measured at days 1, 28, 42 - 56 and 88.
Overall study start date01/01/2007
Completion date31/12/2012

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit4 Years
SexBoth
Target number of participants150
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2007
Date of final enrolment31/12/2012

Locations

Countries of recruitment

  • Czech Republic
  • Denmark
  • France
  • Germany
  • Netherlands
  • Norway
  • Slovakia
  • Sweden

Study participating centre

Carl-Neuberg-Str. 1
Hannover
30625
Germany

Sponsor information

University of Münster (Germany)
University/education

Domagkstr. 5
Münster
48149
Germany

Email ukm@uni-muenster.de
Website http://www.klinikum.uni-muenster.de
ROR logo "ROR" https://ror.org/00pd74e08

Funders

Funder type

Charity

German Cancer Aid (Deutsche Krebshilfe) (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan