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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT00819351

Collaborator

Nordic Society for Pediatric Hematology and Oncology (Other)

650

Enrollment

Locations

Arms

Actual Duration (Months)

108.3

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Drug: PEG Asparaginase at six weeks interval Drug: PEG Asparaginase at two weeks interval	Phase 3

Detailed 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

Study Design

Study Type:

Interventional

Actual Enrollment :

650 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Mar 2, 2016

Actual Study Completion Date :

Mar 2, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PEG-asparaginase 6 weeks intervals PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (from week 13 after diagnosis to week 33). All additional therapy (High Dose Methotrexate, Vincristin, Dexamethasone, 6-Mercaptopurine, doxorubicin, intrathecal chemotherapy) is the same in both arms.	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) Other Names: Oncaspar (PEG-Asparaginase)
Active Comparator: PEG-Asparaginase 2 weeks intervals PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (from week 13 after diagnosis to week 33). All additional therapy (High Dose Methotrexate, Vincristin, Dexamethasone, 6-Mercaptopurine, doxorubicin, intrathecal chemotherapy) is the same in both arms.	Drug: 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) Other Names: Oncaspar (PEG-Asparaginase)

Arm

Intervention/Treatment

Experimental: PEG-asparaginase 6 weeks intervals

PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (from week 13 after diagnosis to week 33). All additional therapy (High Dose Methotrexate, Vincristin, Dexamethasone, 6-Mercaptopurine, doxorubicin, intrathecal chemotherapy) is the same in both arms.

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)

Other Names:

Oncaspar (PEG-Asparaginase)

Active Comparator: PEG-Asparaginase 2 weeks intervals

PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (from week 13 after diagnosis to week 33). All additional therapy (High Dose Methotrexate, Vincristin, Dexamethasone, 6-Mercaptopurine, doxorubicin, intrathecal chemotherapy) is the same in both arms.

Drug: 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)

Other Names:

Oncaspar (PEG-Asparaginase)

Outcome Measures

Primary Outcome Measures

Event Free Survival [6 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Department of Pediatrics, Rigshospitalet	Copenhagen	Denmark	2100
2	Helsinki University Hospital	Helsinki	Finland
3	University Hospital Reykjavik, Iceland	Reykjavik	Iceland
4	Trondheim University Hospital	Trondheim	Norway
5	Department of Pediatrics, Drottning Sylvias Pediatric Hospital	Gothenburg	Sweden
6	NOPHO nordic organisation for pediatric onology	Stockholm	Sweden