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

Acute Lymphoblastic Leukemia Clinical Trial

— ALL2008con  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816049
• Other study ID #: NOPHO ALL2008 consolidation
• Status: Completed
• Phase: Phase 3
• First received: December 23, 2008
• Last updated: April 20, 2017
• Start date: January 2009
• Est. completion date: March 2, 2016

Study information

• Verified date: April 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 775
• Est. completion date: March 2, 2016
• Est. primary completion date: March 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Denmark	Department of Pediatrics, Rigshospitalet	Copenhagen
Finland	Helsinki University Hospital	Helsinki
Iceland	University Hospital	Reykjavik
Norway	Trondheim University Hospital	Trondheim
Sweden	Department of Pediatrics, Drottning Sylvias Pediatric Hospital	Gothenburg
Sweden	NOPHO nordic organisation for pediatric onology	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Nordic Society for Pediatric Hematology and Oncology

Countries where clinical trial is conducted

Denmark,  Finland,  Iceland,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		6 years
Secondary	Toxicity of treatment, degree of myelo-, hepato- and renal toxicity; and development of asparaginase antibodies.		6 years

External Links

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