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

Phase 3

Completed

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Drug: 6MPindividualized; Drug: 6MPfixed

• Registration Number: NCT00816049
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study First Submitted: 2008-12-23
• Study First Submitted QC: 2008-12-30
• Study First Posted: 2008-12-31
• Study Start: 2009-01
• Primary Completion: 2016-03-02
• Study Completion: 2016-03-02
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-20
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 775

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6MPindividualized	6MPindividualized	Individualized dose increments of 6-mercaptopurine days 30-85
6MPfixed	6MPfixed	Fixed dose 6-mercaptopurine days 30-85

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (6)

NOPHO nordic organisation for pediatric onology; 🇸🇪 Stockholm, Sweden

Department of Pediatrics, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Department of Pediatrics, Drottning Sylvias Pediatric Hospital; 🇸🇪 Gothenburg, Sweden

University Hospital; 🇮🇸 Reykjavik, Iceland

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Trondheim University Hospital; 🇳🇴 Trondheim, Norway