Trials / Completed
CompletedNCT00109031
Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- Swedish Orphan Biovitrum · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3 consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World Health Organization \[WHO\] grade 3 and 4).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | palifermin | Administered as one daily intravenous bolus. |
| RADIATION | Total Body Irradiation | To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days. |
| DRUG | Cyclophosphamide | Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2 |
| DRUG | Etoposide | Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction. |
| DRUG | Placebo | Administered as one daily intravenous bolus. |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2006-02-01
- Completion
- 2010-12-01
- First posted
- 2005-04-25
- Last updated
- 2014-09-15
- Results posted
- 2014-09-15
Source: ClinicalTrials.gov record NCT00109031. Inclusion in this directory is not an endorsement.