Condition category
Cancer
Date applied
30/05/2007
Date assigned
02/07/2007
Last edited
17/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://aml.mh-hannover.de/dsml/

Contact information

Type

Scientific

Primary contact

Dr Dirk Reinhardt

ORCID ID

Contact details

Pediatric Hematology/Oncology
Hannover Medical School
Carl-Neuberg-Str. 1
Hannover
30625
Germany
reinhardt.dirk@mh-hannover.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TMD Prevention 2007

Study information

Scientific title

Acronym

TMD Prevention 2007

Study hypothesis

Elimination of the preleukaemic clone in children with Down's syndrome and Transient Myeloproliferative Disorder (TMD) to prevent Acute Myeloid Leukaemia (AML).

As of 17/02/2009 this record was updated to include the following countries of recruitment: Netherlands, Czech Republic, Slovakia.

Ethics approval

Approved by the Ethical Committee of the Hannover Medical School on the 17th November 2006 (ref: 4378M).

Study design

Non-randomised, historically controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Transient myeloproliferative disorder in children with Down's syndrome

Intervention

Experimental intervention:
Monitoring of GATA1s positive preleukemic clones, low-dose cytarabine treatment in children with persisting GATA1s clone.

Control intervention:
None, historical controls are used.

Duration of intervention per patient: three months

Intervention type

Drug

Phase

Not Specified

Drug names

Cytarabine

Primary outcome measures

Reduction of Down's Syndrome Myeloid Leukaemia (DS-ML) risk in children with TMD from 22% to 7%.

Secondary outcome measures

1. Key secondary endpoint: GATA1s negativity (sensitivity 10-3/-4) at week 12
2. Assessment of safety: Serious Adverse Events (SAE)/Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting system, long-term follow-up of late adverse effects, data monitoring committee

Overall trial start date

01/05/2007

Overall trial end date

30/04/2012

Reason abandoned

Eligibility

Participant inclusion criteria

TMD with GATA1s mutation and myeloproliferation (greater than 5% blasts in peripheral blood or bone marrow).

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. No consent
2. No trisomy 21

Recruitment start date

01/05/2007

Recruitment end date

30/04/2012

Locations

Countries of recruitment

Czech Republic, Germany, Netherlands, Slovakia

Trial participating centre

Pediatric Hematology/Oncology
Hannover
30625
Germany

Sponsor information

Organisation

Hannover Medical School (Germany)

Sponsor details

Carl-Neuberg-Str. 1
Hannover
30625
Germany
reinhardt.dirk@mh-hannover.de

Sponsor type

Hospital/treatment centre

Website

http://www.mh-hannover.de/

Funders

Funder type

Research organisation

Funder name

German Research Foundation (Deutsche Forschungsgemeinschaft [DFG]) (Germany) - (ref: RE 2580/1-1)

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