# Fludarabine before CD8+ antigen-specific T-cell clones in stage IV melanoma (Fred Hutchinson phase 1)

Source: https://onco.cc/trials/nct00317759/  
OnCo record `nct00317759` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A Seattle trial that tested whether giving the chemotherapy drug fludarabine before an infusion of a patient's own melanoma-targeting T cells helped the cells survive. The published report found they lasted about three times longer.

## Summary

The registry describes a phase I study of autologous CD8+ antigen-specific T-cell clones following fludarabine lymphodepletion in metastatic melanoma, started in May 2003 and completed in October 2008, with an estimated enrolment of 12; Cassian Yee is listed as principal investigator (ClinicalTrials.gov NCT00317759). The trial's report, which names this registration (FHCRC 1796), gave 19 infusions to 10 patients and found that fludarabine extended median persistence of the transferred clones from 4.5 to 13.0 days (PLoS ONE 2009). No results are posted on the registry.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-11-05
- Registry id: NCT00317759
- Phase: 1
- Setting: Metastatic melanoma: autologous CD8+ antigen-specific T-cell clones following fludarabine lymphodepletion
- Sponsor: Fred Hutchinson Cancer Center, with the National Cancer Institute
- Result: Published report: fludarabine improved in vivo persistence of transferred CTL clones 2.9-fold, from a median of 4.5 to 13.0 days, in 10 patients (PLoS ONE 2009). No results posted on ClinicalTrials.gov.

## Sources

- ClinicalTrials.gov NCT00317759: https://clinicaltrials.gov/study/NCT00317759
- DOI 10.1371/journal.pone.0004749: https://doi.org/10.1371/journal.pone.0004749

## Connected records

- cancers: [Melanoma](https://onco.cc/cancers/melanoma/)
- drugs: [Fludarabine](https://onco.cc/drugs/fludarabine/)
- institutions: [Fred Hutchinson Cancer Center](https://onco.cc/institutions/fred-hutch/), [National Cancer Institute (NIH)](https://onco.cc/institutions/nci/)
- terms: [Endogenous T-cell therapy](https://onco.cc/terms/endogenous-t-cell-therapy/), [Lymphodepletion before CAR-T](https://onco.cc/terms/lymphodepletion/)
- people: [Cassian Yee](https://onco.cc/people/cassian-yee/)
- key papers: [Fludarabine modulates immune response and extends in vivo survival of adoptively transferred CD8 T cells in patients with metastatic melanoma](https://onco.cc/key-papers/paper-wallen-fludarabine-ctl-melanoma-plos-one-2009/)

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