ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy
ALL2008con
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
1 other identifier
interventional
775
5 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2009
Longer than P75 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2008
CompletedFirst Posted
Study publicly available on registry
December 31, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2016
CompletedApril 21, 2017
April 1, 2017
7.2 years
December 23, 2008
April 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Toxicity of treatment, degree of myelo-, hepato- and renal toxicity; and development of asparaginase antibodies.
6 years
Study Arms (2)
6MPfixed
ACTIVE COMPARATORFixed dose 6-mercaptopurine days 30-85
6MPindividualized
EXPERIMENTALIndividualized dose increments of 6-mercaptopurine days 30-85
Interventions
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
Oral 6-mercaptopurine at a fixed dose of 25 mg/m2 treatment days 30-85
Eligibility Criteria
You may qualify if:
- Childhood ALL
- All mandatory biological data are available6
- Written informed consent has been obtained
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Department of Pediatrics, Rigshospitalet
Copenhagen, Denmark
Helsinki University Hospital
Helsinki, Finland
University Hospital
Reykjavik, Iceland
Trondheim University Hospital
Trondheim, Norway
Department of Pediatrics, Drottning Sylvias Pediatric Hospital
Gothenburg, Sweden
NOPHO nordic organisation for pediatric onology
Stockholm, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kjeld Schmiegelow, M.D.
Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 23, 2008
First Posted
December 31, 2008
Study Start
January 1, 2009
Primary Completion
March 2, 2016
Study Completion
March 2, 2016
Last Updated
April 21, 2017
Record last verified: 2017-04