ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy (ALL2008con)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
775 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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