ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG Asparaginase

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

NOPHO Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults(18.0-45.0 Years) With Acute Lymphoblastic Leukemia. Intermittent Versus Continuous PEG-asparaginase for Asparagine Depletion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819351
• Other study ID #: NOPHO ALL2008 PEG Asparaginase
• Status: Completed
• Phase: Phase 3
• First received: January 8, 2009
• Last updated: April 20, 2017
• Start date: January 1, 2009
• Est. completion date: March 2, 2016

Study information

• Verified date: April 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of Event Free Survival

Description:

20% of children with ALL still fails to be cured. The ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000 protocol and previous NOPHO protocols.

The specific and primary objectives of the randomised study is:

To test if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of EFS. As secondary endpoints asparaginase antibody production and toxicity including allergic reactions in the treatment-arms will be analysed

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: March 2, 2016
• Est. primary completion date: March 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 45 Years

Eligibility

Inclusion Criteria:

• Childhood ALL

• All mandatory biological data are available6

• Written informed consent has been obtained

Exclusion Criteria:

• Bilineage ALL

• Pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week

• ALL predisposition syndromes

• Previous cancer

• Off protocol administration of additional chemotherapy during induction therapy

• Sexually active females not using contraception

• No allergic reactions to PEG Asparaginase

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• PEG Asparaginase at six weeks interval
PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (until the patient has received 33 weeks of therapy)
• PEG Asparaginase at two weeks interval
PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (until the patient has received 33 weeks of therapy)

Locations

Country	Name	City	State
Denmark	Department of Pediatrics, Rigshospitalet	Copenhagen
Finland	Helsinki University Hospital	Helsinki
Iceland	University Hospital Reykjavik, Iceland	Reykjavik
Norway	Trondheim University Hospital	Trondheim
Sweden	Department of Pediatrics, Drottning Sylvias Pediatric Hospital	Gothenburg
Sweden	NOPHO nordic organisation for pediatric onology	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Nordic Society for Pediatric Hematology and Oncology

Countries where clinical trial is conducted

Denmark,  Finland,  Iceland,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event Free Survival		6 years
Secondary	Secondary Outcome Measures are toxicity (special focus on thrombosis, pancreatitis, and allergic reactions), the formation of silent antibodies, and the influence of antibody production on the EFS.		6 years

External Links

•   Home Page of NOPHO-most areas are closed