Condition category
Cancer
Date applied
17/02/2009
Date assigned
19/03/2009
Last edited
19/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.klinikum.uni-muenster.de

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes