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| Name | Class |
|---|---|
| Nordic Society for Pediatric Hematology and Oncology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6MPfixed | Active Comparator | Fixed dose 6-mercaptopurine days 30-85 |
|
| 6MPindividualized | Experimental | Individualized dose increments of 6-mercaptopurine days 30-85 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6MPindividualized | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity of treatment, degree of myelo-, hepato- and renal toxicity; and development of asparaginase antibodies. | 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kjeld Schmiegelow, M.D. | Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Rigshospitalet | Copenhagen | Denmark | ||||
| Helsinki University Hospital |
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| Label | URL |
|---|---|
| Home page of NOPHO - most areas are closed | View source |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015122 | Mercaptopurine |
| ID | Term |
|---|---|
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011687 | Purines |
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|
| 6MPfixed | Drug | Oral 6-mercaptopurine at a fixed dose of 25 mg/m2 treatment days 30-85 |
|
|
| 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 |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |