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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


Phase 3
1 Year
45 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Event Free Survival

Outcome Time Frame:

6 years

Safety Issue:

No

Principal Investigator

Kjeld Schmiegelow, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen

Authority:

Denmark: Danish Medicines Agency

Study ID:

NOPHO ALL2008 PEG Asparaginase

NCT ID:

NCT00819351

Start Date:

February 2009

Completion Date:

June 2017

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • acute lymphoblastic leukemia
  • child
  • PEG-Asparaginase
  • EFS
  • efficacy
  • childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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