Condition category
Cancer
Date applied
28/02/2007
Date assigned
28/02/2007
Last edited
28/02/2007
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

Dr J G de Ridder-Sluiter

ORCID ID

Contact details

Dutch Childhood Oncology Group (Stichting Kinder Oncologie [SKION])
Leyweg 299
Den Haag
2545 CJ
Netherlands
+31 (0)70 367 4545
hderidder@skion.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SNWLK/DCOG ALL-9

Study information

Scientific title

Acronym

Study hypothesis

The dutch ALL-6 protocol (1984 - 1988) for standard risk childhood Acute Lymphoblastic Leukaemia (ALL) was one of the first to use dexamethasone as a steroid instead of prednisone. This led to surprisingly good results. The ALL-9 protocol thus was meant to reproduce these results and to extend the use to patients with high risk ALL.

This reduced intensity protocol is instituted to:
1. Confirm the data obtained in the SNWLK-ALL-6 protocol for standard risk patients
2. Offer significant improvement of cure rate in high risk patients, comparable to international childhood ALL protocols
3. Offer the possibility to conduct window studies with monotherapy
4. Validate the prognostic significance of in vitro drug resistance testing
5. Standardise the minimal residual disease test
6. Evaluate the side effects, especially osteonecrosis and psychological effects of dexamethasone

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, non-randomised, non-controlled, clinical trial

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute Lymphoblastic Leukaemia (ALL)

Intervention

Stratification into standard risk and high risk.

Intervention type

Drug

Phase

Not Specified

Drug names

Dexamethasone

Primary outcome measures

Survival

Secondary outcome measures

Event free survival

Overall trial start date

01/01/1997

Overall trial end date

30/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

All children with acute lymphoblastic leukaemia from one year (365 days) until 18 years of age, excluding mature B-cell ALL.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

918

Participant exclusion criteria

1. Mature B-cell ALL
2. Relapsed ALL
3. Secondary ALL
4. Pretreatment with corticosteroids or cytostatic drugs in the four weeks preceding diagnosis
5. Patient of whom essential diagnostic tests are missing
6. Patients in whom essential parts of therapy were not given

Recruitment start date

01/01/1997

Recruitment end date

30/10/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Dutch Childhood Oncology Group (Stichting Kinder Oncologie [SKION])
Den Haag
2545 CJ
Netherlands

Sponsor information

Organisation

Dutch Childhood Oncology Group (Stichting Kinder Oncologie [SKION]) (The Netherlands)

Sponsor details

Leyweg 299
Amsterdam
2545 CJ
Netherlands
+31 (0)70 367 4545
info@skion.nl

Sponsor type

Research organisation

Website

http://www.skion.nl/

Funders

Funder type

Government

Funder name

Dutch governmental grant (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dutch Health Insurance (The Netherlands)

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