ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00816049

Acronym

ALL2008con

Enrollment

775

Registered

2008-12-31

Start date

2009-01-31

Completion date

2016-03-02

Last updated

2017-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

Keywords

acute lymphoblastic leukemia, child, 6-mercaptopurine, minimal residual disease, efficacy, childhood acute lymphoblastic leukemia

Brief summary

The purpose of this study is to increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualized intensification of the 6MP-dosage days 30-85.

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 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.

Interventions

DRUG6MPindividualized

Oral 6-mercaptopurine with a starting dose of 25 mg/m2 and upward adjusted in steps of 25 mg/m2 (i.e. 50 or 75 mg/m2) if unacceptable bone-marrox toxicity is not encountered

DRUG6MPfixed

Oral 6-mercaptopurine at a fixed dose of 25 mg/m2 treatment days 30-85

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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)	6 years

Secondary

Measure	Time frame
Toxicity of treatment, degree of myelo-, hepato- and renal toxicity; and development of asparaginase antibodies.	6 years

Countries

Denmark, Finland, Iceland, Norway, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026