# Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)

Source: https://onco.cc/trials/nct00109031/  
OnCo record `nct00109031` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Palifermin, Cyclophosphamide and Etoposide in Leukaemia, run by Swedish Orphan Biovitrum, completed.

## Summary

Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE) is a phase 3 interventional study registered as NCT00109031 by Swedish Orphan Biovitrum, with 47 participants recorded, started 2005-01 and reaching its primary completion in 2006-02. Interventions recorded: palifermin, Total Body Irradiation, Cyclophosphamide, Etoposide, Placebo. Conditions recorded: Cancer, Lymphoma, Leukemia.

Linked to the drug Palifermin because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-22
- Tags: pipeline; ctgov-ingest
- Registry id: NCT00109031
- Phase: 3
- Setting: A Randomized, Blinded, Active-control Trial of Palifermin (rHuKGF) to Evaluate Oral Mucositis in Subjects With Hematologic Malignancies Undergoing Fractionated Total Body Irradiation (fTBI) and High Dose Chemotherapy With Autologous Peripheral Blood Progenitor Cell (PBPC) Transplantation
- Sponsor: Swedish Orphan Biovitrum
- Enrolled: 47

## Sources

- ClinicalTrials.gov NCT00109031: https://clinicaltrials.gov/study/NCT00109031

## Connected records

- cancers: [Leukaemia (all types)](https://onco.cc/cancers/leukaemia/)
- drugs: [Cyclophosphamide](https://onco.cc/drugs/cyclophosphamide/), [Etoposide](https://onco.cc/drugs/etoposide/), [Palifermin](https://onco.cc/drugs/palifermin/)
- companies: [Sobi (Swedish Orphan Biovitrum)](https://onco.cc/companies/sobi/)

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