Neoplasms

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Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

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Hematologic Diseases

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Immunoproliferative Disorders

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Mercaptopurine

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Enzyme Inhibitors

Individualized dose increments of 6-mercaptopurine days 30-85

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

6MPindividualized

Oral 6-mercaptopurine at a fixed dose of 25 mg/m2 treatment days 30-85

6MPfixed

Kjeld Schmiegelow, M.D.

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.

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.

ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy

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

Nordic Society for Pediatric Hematology and Oncology

Rigshospitalet, Denmark

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy	NCT00816049	Acute Lymphobla...	6MPindividualiz... 6MPfixed	1 Year - 45 Years	Rigshospitalet, Denmark
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy	NCT00816049	Acute Lymphobla...	6MPindividualiz... 6MPfixed	1 Year - 45 Years	Rigshospitalet, Denmark

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