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Brief Title: 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 ID: NCT00816049
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.
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Kjeld Schmiegelow, M.D.
Affiliation: Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen
Role: STUDY_CHAIR