Clinical trial NCT00816049: ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Lymphoblastic Leukemia
Keywords: acute lymphoblastic leukemia
child
6-mercaptopurine
minimal residual disease
efficacy
childhood acute lymphoblastic leukemia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Nordic Society for Pediatric Hematology and Oncology
First posted: 2008-12-31
Enrollment: 775
Sex: ALL
Minimum age (years): 1
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 6 years
Secondary outcomes:
measure: Toxicity of treatment, degree of myelo-, hepato- and renal toxicity; and development of asparaginase antibodies.
timeFrame: 6 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Pediatrics, Rigshospitalet
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Reykjavik
country: Iceland
facility: University Hospital
city: Trondheim
country: Norway
facility: Trondheim University Hospital
city: Gothenburg
country: Sweden
facility: Department of Pediatrics, Drottning Sylvias Pediatric Hospital
city: Stockholm
country: Sweden
facility: NOPHO nordic organisation for pediatric onology
Study officials:
affiliation: Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen
name: Kjeld Schmiegelow, M.D.
role: STUDY_CHAIR
References: