Clinical trial · Observational
Severe Toxicity Free Survival Following Childhood Acute Lymphoblastic Leukemia
- 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 goal of this observational study is to quantify the burden of particularly severe, long-term adverse effects in childhood acute lymphoblastic leukemia (ALL) survivors. The adverse effects include 21 severe health conditions recently selected and defined as Severe Toxicities by an international collaboration of ALL consortia. The main questions the study aims to answer for childhood ALL patients are: * What is the chance of surviving without any Severe Toxicities during the first 5 years after ALL diagnosis? * What is the average cumulative burden of different Severe Toxicities during the first 5 years after ALL diagnosis? The study uses standard-care follow-up data for childhood ALL patients from an international collaboration of five ALL consortia from Europe, the US, and Australia.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (5)
- label
- NOPHO ALL2008
- description
- Children and adolescents treated according to the NOPHO ALL2008 protocol
- label
- Australia
- label
- Poland
- label
- Dutch Childhood Oncology Group
- label
- St. Jude
Primary outcomes (2)
- measure
- Severe-Toxicity-Free Survival
- timeFrame
- Within 5 years after ALL diagnosis
- description
- Time from ALL diagnosis to the first event of a Severe Toxicity or death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with ALL ≥5 years ago * \<18 years of age at time of ALL diagnosis Exclusion Criteria: * None
References
Publications (2)
- BACKGROUNDAndres-Jensen L, Attarbaschi A, Bardi E, Barzilai-Birenboim S, Bhojwani D, Hagleitner MM, Halsey C, Harila-Saari A, van Litsenburg RRL, Hudson MM, Jeha S, Kato M, Kremer L, Mlynarski W, Moricke A, Pieters R, Piette C, Raetz E, Ronceray L, Toro C, Grazia Valsecchi M, Vrooman LM, Weinreb S, Winick N, Schmiegelow K; Ponte di Legno Severe Toxicity Working Group. Severe toxicity free survival: physician-derived definitions of unacceptable long-term toxicities following acute lymphocytic leukaemia. Lancet Haematol. 2021 Jul;8(7):e513-e523. doi: 10.1016/S2352-3026(21)00136-8. PMID 34171282
- BACKGROUNDNielsen CG, Thomsen BL, Als-Nielsen B, Conyers R, Jeha S, Mateos MK, Mlynarski W, Pieters R, Rathe M, Schmiegelow K, Andres-Jensen L. Physician-defined severe toxicities occurring during and after cancer treatment: Modified consensus definitions and clinical applicability in the evaluation of cancer treatment. Front Pediatr. 2023 Apr 26;11:1155449. doi: 10.3389/fped.2023.1155449. eCollection 2023. PMID 37181427