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Nordic Society of Paediatric Haematology and Oncology Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults (18-45 Years of Age) With ALL. Efficacy of Individualised 6MP Dosing During Consolidation Therapy


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

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Trial Information

Nordic Society of Paediatric Haematology and Oncology Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults (18-45 Years of Age) With ALL. Efficacy of Individualised 6MP Dosing During Consolidation Therapy


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 increase the fraction of patients, who become MRD-negative during consolidation for the
non-HR ALL group through individualised intensification of the 6MP-dosage days 30-85. We
will additionally measure EFS and toxicity as secondary end points of effect.


Inclusion Criteria:



- Childhood ALL

- All mandatory biological data are available6

- Written informed consent has been obtained

Exclusion Criteria:

- Mixed lineage 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

- TPMT-deficiency

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Fraction of patients that become MRD-negative at treatment days 85 and/or 92 (end-of-consolidation) and event-free survival. MRD is measured either by Flow-cytometry (for PreB-ALL patients) or PCR for clonal generearrangements(for T-ALL patients)

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 consolidation

NCT ID:

NCT00816049

Start Date:

June 2009

Completion Date:

June 2017

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • acute lymphoblastic leukemia
  • child
  • 6-mercaptopurine
  • minimal residual disease
  • efficacy
  • childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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