A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT
Public ClinicalTrials.gov record NCT00460421. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Pediatric Subjects With Acute Leukemias Undergoing Myeloablative Therapy and Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
Study identification
- NCT ID
- NCT00460421
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Swedish Orphan Biovitrum
- Industry
- Enrollment
- 27 participants
Conditions and interventions
Conditions
Interventions
- Palifermin Drug
- Total Body irradiation Radiation
- Chemotherapy Drug
Drug · Radiation
Eligibility (public fields only)
- Age range
- 1 Year to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2006
- Primary completion
- Apr 30, 2011
- Completion
- Apr 30, 2011
- Last update posted
- Dec 4, 2014
2006 – 2011
United States locations
- U.S. sites
- 7
- U.S. states
- 4
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Cancer Center | Tucson | Arizona | — | — |
| Loma Linda University | Loma Linda | California | — | — |
| Children´s Hospital | Los Angeles | California | — | — |
| Regents of University of California | Los Angeles | California | — | — |
| Children´s Hospital of Orange | Orange | California | — | — |
| Children´s Memorial | Chicago | Illinois | — | — |
| University of Texas | Dallas | Texas | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00460421, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 4, 2014 · Synced Jul 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00460421 live on ClinicalTrials.gov.