ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy
NCT ID: NCT00816049
Last Updated: 2017-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
775 participants
INTERVENTIONAL
2009-01-31
2016-03-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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6MPfixed
Fixed dose 6-mercaptopurine days 30-85
6MPfixed
Oral 6-mercaptopurine at a fixed dose of 25 mg/m2 treatment days 30-85
6MPindividualized
Individualized dose increments of 6-mercaptopurine days 30-85
6MPindividualized
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
Interventions
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6MPindividualized
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
6MPfixed
Oral 6-mercaptopurine at a fixed dose of 25 mg/m2 treatment days 30-85
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All mandatory biological data are available6
* Written informed consent has been obtained
Exclusion Criteria
* 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
1 Year
45 Years
ALL
No
Sponsors
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Nordic Society for Pediatric Hematology and Oncology
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Kjeld Schmiegelow
Professor
Principal Investigators
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Kjeld Schmiegelow, M.D.
Role: STUDY_CHAIR
Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen
Locations
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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
Countries
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Other Identifiers
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NOPHO ALL2008 consolidation
Identifier Type: -
Identifier Source: org_study_id
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