CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 500 target
Drug / intervention
Observationalother
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Newly diagnosed T-lymphoblastic or B-lymphoblastic precursor leukaemia (ALL) confirmed by accredited laboratory
  • ✓Age 0 to <46 years at time of diagnosis (with exception for infants with KMT2A-r BCP ALL)
  • ✓Surface immunoglobulin negative (sIG-) BCP-ALL with IG::MYC rearrangement unless concurrent BCL2/6 rearrangement, or T-ALL with MYC translocations
  • ✓Informed consent signed by patient and/or parents/legal guardians
Key exclusion· 13
  • ✕Age <365 days with KMT2A-rearranged BCP-ALL
  • ✕Age >45 years at diagnosis
  • ✕Previous malignant diagnosis or ALL as second malignant neoplasm
  • ✕Relapse of ALL

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03911128
NCT03911128N/ARecruitingOn TrackUpdated 9mo ago
Long Recruiting
CompareCT.gov

A Treatment Study Protocol of the ALLTogether Consortium for Infants, Children and Young Adults (0-45 Years of Age) With Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL): a Pilot Study

Mats Heyman·observational·Posted Apr 10, 2019·Updated Sep 2, 2025

In Brief

An observational study evaluating Observational for Leukemia, Acute Lymphoblastic. Currently recruiting, targeting 500 participants across 53 sites in 8 countries.

Detailed Summary

The pilot study collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new platform protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised trials included in the study-design. The pilot study is implemented as a master protocol without study specific interventions, thus as an observational study. The pilot study is for countries/study-groups who intend to join ALLTogether1 (including experimental interventions). For these countries the pilot study is crucial to optimise diagnostics, registration systems, collaborations with vendors, logistics and data-checks before starting the main study. The study only includes "standard of care" treatment included in the master protocol.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Acute Lymphoblastic
CountriesDenmark, Estonia, Finland, Iceland, Lithuania, Norway, Spain, Sweden
CollaboratorsNordic Society for Pediatric Hematology and Oncology, The Swedish Childhood Cancer Foundation, NordForsk

Timeline

N/ARecruiting
201920202021202220232024202520262027202820292030203120322033
First PostedApr 10, 2019
Enrollment StartAug 29, 2019
Primary CompletionJun 1, 2033
TodayJul 2, 2026
Enrollment to primary: 13.8 yearsPosted 7.2 years agoPrimary completion in 6.9 years

Interventions

Observationalother

Observational study - no intervention