Clinical trial · Interventional
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
NCT00816049CI-TRIAL-00027132ALL2008concompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6MPfixed | Drug | — | UNRESOLVED |
| 6MPindividualized | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 6MPfixed
- description
- Fixed dose 6-mercaptopurine days 30-85
- interventionNames
- Drug: 6MPfixed
- type
- EXPERIMENTAL
- label
- 6MPindividualized
- description
- Individualized dose increments of 6-mercaptopurine days 30-85
- interventionNames
- Drug: 6MPindividualized
Primary outcomes (1)
- measure
- 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)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.