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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00816049 |
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Date of registration:
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23/12/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy
ALL2008con |
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Scientific title:
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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 |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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775 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00816049 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Denmark
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Finland
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Iceland
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Norway
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Sweden
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Contacts
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Name:
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Kjeld Schmiegelow, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen |
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Key inclusion & exclusion criteria
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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
Age minimum:
1 Year
Age maximum:
45 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acute Lymphoblastic Leukemia
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Intervention(s)
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Drug: 6MPfixed
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Drug: 6MPindividualized
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Primary Outcome(s)
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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)
[Time Frame: 6 years]
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Secondary Outcome(s)
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Toxicity of treatment, degree of myelo-, hepato- and renal toxicity; and development of asparaginase antibodies.
[Time Frame: 6 years]
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Secondary ID(s)
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NOPHO ALL2008 consolidation
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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