# ALFA-0701

Source: https://onco.cc/trials/alfa-0701/  
OnCo record `alfa-0701` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

ALFA-0701 was the trial that rescued the first ADC: giving gemtuzumab in three small doses with chemotherapy improved event-free survival without the toxicity that got it withdrawn.

## Summary

Gemtuzumab 3 mg/m² on days 1, 4, 7. Median EFS 17.3 vs 9.5 months (HR 0.56, 95% CI 0.42-0.76); relapse-free survival improved; OS not significantly different in the final analysis (27.5 vs 21.8 months). Lancet 2012; basis of the 2017 US re-approval. Meta-analysis of five trials confirmed OS benefit in favourable- and intermediate-risk cytogenetics.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT00927498
- Phase: 3
- Setting: Newly diagnosed de novo AML, age 50-70: fractionated gemtuzumab ozogamicin added to 7+3 vs 7+3 alone
- Sponsor: ALFA group (France)
- Enrolled: 280
- Result: EFS 17.3 vs 9.5 months; HR 0.56.
- Outcomes: Event-free survival (median): GO + 7+3 17.3 months vs 7+3 9.5 months, HR 0.56; Overall survival (median): GO + 7+3 27.5 months vs 7+3 21.8 months
- Replication: Hills et al. meta-analysis (Lancet Oncology 2014, 3,325 patients) confirmed reduced relapse and improved OS in favourable/intermediate cytogenetics, none in adverse risk.

## Sources

- ClinicalTrials.gov NCT00927498: https://clinicaltrials.gov/study/NCT00927498

## Connected records

- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/)
- targets: [CD33](https://onco.cc/targets/cd33/)
- drugs: [Cytarabine + anthracycline ('7+3')](https://onco.cc/drugs/cytarabine-7-3/), [Gemtuzumab ozogamicin](https://onco.cc/drugs/gemtuzumab-ozogamicin/)
- companies: [ALFA (Acute Leukemia French Association)](https://onco.cc/companies/alfa/)
- trials: [COG AAML0531](https://onco.cc/trials/aaml0531/)

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