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

Condition(s) targeted: Acute Lymphoblastic Leukemia

Intervention: PEG Asparaginase at six weeks interval (Drug); PEG Asparaginase at two weeks interval (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Rigshospitalet, Denmark

Official(s) and/or principal investigator(s):
Kjeld Schmiegelow, M.D., Study Chair, Affiliation: Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen

Overall contact:
Kjeld Schmiegelow, M.D., Phone: +45 35451357, Email: kschmiegelow@rh.regionh.dk

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

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Event Free Survival

Secondary outcome: 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.

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

Minimum age: 1 Year. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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

Kjeld Schmiegelow, M.D., Phone: +45 35451357, Email: kschmiegelow@rh.regionh.dk

Department of Pediatrics, Rigshospitalet, Copenhagen 2100, Denmark; Recruiting
Kjeld Schmiegelow, M.D., Phone: +4535451357, Email: kschmiegelow@rh.regionh.dk
Thomas Frandsen, M.D., Phone: +4535458364, Email: thomas.leth.frandsen@rh.regionh.dk

Helsinki University Hospital, Helsinki, Finland; Recruiting
Kim Vettenranta, M.D., Phone: + 35 850-3676528, Email: kim.vettenranta@hus.fi

University Hospital Reykjavik, Iceland, Reykjavik, Iceland; Recruiting
Olafur Jonsson, M.D., Phone: +354 5431000, Email: olafurgi@landspitali.is

Trondheim University Hospital, Trondheim, Norway; Recruiting
Ann Åsberg, M.D., Phone: + 47 92626432, Email: ann.asberg@ntnu.no

Department of Pediatrics, Drottning Sylvias Pediatric Hospital, Gothenburg, Sweden; Recruiting
Jonas Abrahamson, M.D., Phone: 46-707-69-5159, Email: jonas.abrahamsson@vgregion.se

NOPHO nordic organisation for pediatric onology, Stockholm, Sweden; Recruiting
Mats Heyman, M.D., Phone: +46 706287698, Email: mats.heyman@ki.se
Thomas Frandsen, M.D., Phone: +45 3545 8364, Email: t-frandsen@dadlnet.dk
Stefan Söderhäll, M.D., Principal Investigator

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Starting date: February 2009
Last updated: May 22, 2012