# RATIFY (CALGB 10603)

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

## TL;DR

The trial that made FLT3 the first targetable mutation in AML: adding midostaurin to chemotherapy tripled median survival.

## Summary

3,277 patients screened to randomise 717 with FLT3-ITD or TKD mutations. Median OS 74.7 vs 25.6 months (HR 0.78, 95% CI 0.63-0.96, p=0.009); 4-year OS 51.4% vs 44.3%; benefit across ITD allelic ratio and TKD subgroups and irrespective of transplant. NEJM 2017. Established the template of TKI added to intensive induction that QuANTUM-First later refined.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT00651261
- Phase: 3
- Setting: Newly diagnosed FLT3-mutated AML, age 18-59: midostaurin vs placebo added to 7+3, consolidation, and one year of maintenance
- Sponsor: Alliance / Novartis
- Enrolled: 717
- Result: Median OS 74.7 vs 25.6 months; HR 0.78.
- Outcomes: Overall survival (median): Midostaurin + 7+3 74.7 months vs Placebo + 7+3 25.6 months, HR 0.78; 4-year overall survival: Midostaurin 51.4% vs Placebo 44.3%
- Replication: QuANTUM-First (quizartinib) independently confirmed that FLT3 inhibition added to 7+3 improves OS in FLT3-ITD AML; real-world registries reproduce the RATIFY benefit in patients up to age 70.

## Sources

- ClinicalTrials.gov NCT00651261: https://clinicaltrials.gov/study/NCT00651261
- NEJM 2017: https://www.nejm.org/doi/full/10.1056/NEJMoa1614359

## Connected records

- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/), [FLT3-mutated acute myeloid leukaemia](https://onco.cc/cancers/aml-flt3/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [FLT3](https://onco.cc/targets/flt3/)
- drugs: [Cytarabine + anthracycline ('7+3')](https://onco.cc/drugs/cytarabine-7-3/), [Midostaurin](https://onco.cc/drugs/midostaurin/)
- companies: [Alliance for Clinical Trials in Oncology](https://onco.cc/companies/alliance-oncology/), [Novartis](https://onco.cc/companies/novartis/)
- terms: [ELN 2022 risk classification](https://onco.cc/terms/eln-risk/), [FLT3-ITD allelic ratio](https://onco.cc/terms/flt3-itd-allelic-ratio/)
- people: [Richard M. Stone](https://onco.cc/people/richard-stone/)
- pairings: [FLT3 inhibitor + intensive chemotherapy](https://onco.cc/pairings/flt3i-plus-7-3/)
- key papers: [RATIFY: midostaurin added to chemotherapy for acute myeloid leukaemia with a FLT3 mutation](https://onco.cc/key-papers/paper-ratify-midostaurin-nejm-2017/)

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