# CPX-351 Study 301

Source: https://onco.cc/trials/cpx-351-301/  
OnCo record `cpx-351-301` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Repackaging two old chemotherapies into liposomes doubled five-year survival in older adults with the worst kinds of AML.

## Summary

CPX-351 Study 301, trial NCT01696084 sponsored by Celator, now Jazz, and published in JCO in 2018 with a five-year update in Lancet Haematology in 2021, showed that repackaging daunorubicin and cytarabine into liposomes doubled five-year survival in adults aged 60 to 75 with newly diagnosed high-risk or secondary acute myeloid leukaemia. It randomised 309 patients to CPX-351 or conventional 7+3 chemotherapy, met its primary overall survival endpoint, raised the remission rate, and more patients reached transplant with longer survival afterwards. OnCo links it to acute myeloid leukaemia, the CPX-351 record and the 7+3 regimen. There is no second randomised trial, although the UK NCRI AML19 trial and real-world registries report comparable remission rates in secondary disease, and whether the benefit holds in younger patients or against venetoclax-based regimens is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT01696084
- Phase: 3
- Setting: Newly diagnosed high-risk or secondary AML, age 60-75: CPX-351 vs conventional 7+3
- Sponsor: Celator / Jazz
- Enrolled: 309
- Result: OS 9.56 vs 5.95 months, HR 0.69; 5-year OS 18% vs 8%.
- Outcomes: Overall survival (median): CPX-351 9.56 months vs 7+3 5.95 months, HR 0.69; 5-year overall survival: CPX-351 18% vs 7+3 8%
- Replication: No second randomised trial; UK NCRI AML19 and real-world registries report comparable remission rates in secondary AML.

## Sources

- ClinicalTrials.gov NCT01696084: https://clinicaltrials.gov/study/NCT01696084

## Connected records

- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/), [Secondary and therapy-related acute myeloid leukaemia](https://onco.cc/cancers/aml-secondary/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [CPX-351 (liposomal daunorubicin-cytarabine)](https://onco.cc/drugs/cpx-351/), [Cytarabine + anthracycline ('7+3')](https://onco.cc/drugs/cytarabine-7-3/)
- companies: [Jazz Pharmaceuticals](https://onco.cc/companies/jazz/)

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