# ALL R3 (UKALLR3)

Source: https://onco.cc/trials/ukallr3/  
OnCo record `ukallr3` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

ALL R3 found, to the investigators' surprise, that using mitoxantrone instead of idarubicin in the first block of treatment for children whose leukaemia had relapsed nearly doubled the chance of being alive without progression three years later, and mitoxantrone-based reinduction became the standard.

## Summary

ALL R3 was an open-label randomised trial in 22 centres in the United Kingdom and Ireland and nine in Australia and New Zealand for children with a first relapse of acute lymphoblastic leukaemia. Patients were stratified into high-, intermediate- and standard-risk groups by the duration of first remission, site of relapse and immunophenotype, and randomised to idarubicin or mitoxantrone during induction. After three treatment blocks, high-risk patients and intermediate-risk patients with high residual disease went to allogeneic transplant; the rest continued chemotherapy.

Of 239 registered patients, 216 were randomised. Three-year progression-free survival was 64.6 percent with mitoxantrone against 35.9 percent with idarubicin, and three-year overall survival 69.0 against 45.2 percent; the difference came from fewer disease events rather than fewer treatment deaths. The result was unexpected and the randomisation was stopped early. Mitoxantrone-based reinduction became the reference arm of later relapse trials including IntReALL, and the corpus's relapsed childhood leukaemia page names it as the reinduction backbone.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-22
- Also known as: UKALLR3; ALLR3; ALL R3; CCLG-ALLR3
- Tags: soc-trials
- Registry id: NCT00967057
- Phase: 3
- Setting: Children aged 1 to 18 with a first relapse of acute lymphoblastic leukaemia in the United Kingdom, Ireland, Australia and New Zealand: reinduction with idarubicin or mitoxantrone alongside dexamethasone, vincristine, asparaginase and methotrexate, with later therapy and transplant decided by risk group and measurable residual disease
- Sponsor: Children's Cancer and Leukaemia Group
- Enrolled: 216
- Result: Three-year progression-free survival 64.6 percent with mitoxantrone against 35.9 percent with idarubicin, and overall survival 69.0 against 45.2 percent; the randomisation was stopped early.
- Outcomes: Progression-free survival at 3 years: Mitoxantrone reinduction 64.6% vs Idarubicin reinduction 35.9%; Overall survival at 3 years: Mitoxantrone reinduction 69% vs Idarubicin reinduction 45.2%; Disease events (progression, second relapse, disease-related death), hazard for mitoxantrone against idarubicin: Mitoxantrone reinduction vs Idarubicin reinduction, HR 0.56

## Sources

- ClinicalTrials.gov NCT00967057: https://clinicaltrials.gov/study/NCT00967057

## Connected records

- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [Leukaemia (all types)](https://onco.cc/cancers/leukaemia/), [Relapsed and refractory acute lymphoblastic leukaemia in children](https://onco.cc/cancers/all-paediatric-relapsed/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [MRD / molecular residual disease testing](https://onco.cc/technologies/mrd-testing/)
- drugs: [Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase)](https://onco.cc/drugs/asparaginase/), [Dexamethasone](https://onco.cc/drugs/dexamethasone/), [Idarubicin](https://onco.cc/drugs/idarubicin/), [Methotrexate](https://onco.cc/drugs/methotrexate/), [Mitoxantrone](https://onco.cc/drugs/mitoxantrone/)
- key papers: [ALL R3: mitoxantrone versus idarubicin in first relapse of childhood acute lymphoblastic leukaemia](https://onco.cc/key-papers/paper-all-r3-mitoxantrone-relapsed-childhood-all-parker-lancet-2010/)

---
JSON: https://onco.cc/api/v1/entities/ukallr3.json