A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT

PHASE1CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Leukemia
Interventions
DRUG

Palifermin

Palifermin will be administered as an IV bolus injection (40, 60 or 80 µg/kg/day)once daily for 3 consecutive days before the start of conditioning regimen and after HCST (Day -10, -9, -8 and Day 0, +1, +2 respectively).

RADIATION

Total Body irradiation

DRUG

Chemotherapy

High dose etoposide, Cyclophosphamide

Trial Locations (7)

Unknown

Arizona Cancer Center, Tucson

Loma Linda University, Loma Linda

Children´s Hospital, Los Angeles

Regents of University of California, Los Angeles

Children´s Hospital of Orange, Orange

Children´s Memorial, Chicago

University of Texas, Dallas

Sponsors
All Listed Sponsors
lead

Swedish Orphan Biovitrum

INDUSTRY