At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) requiring HSCT
- ✓Age 1 to 16 years at screening
- ✓Lansky performance status >60%
- ✓Adequate renal function: serum creatinine ≤1.5 mg/dL or creatinine clearance/GFR ≥60 mL/min/1.73m²
- ✕Prior treatment with palifermin or other keratinocyte growth factors
- ✕Received investigational product/device (except investigational stem cell separators) within 30 days before enrollment
- ✕Known life-threatening infection not responding well to treatment
- ✕History of hepatic veno-occlusive disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating Palifermin, Total Body irradiation, and 1 other intervention for Leukemia. Completed, enrolled 27 participants across 7 sites.
Detailed Summary
20010133 is an open-label, dose escalation study in pediatric patients with acute leukemias receiving myelotoxic therapy (high dose etoposide, cyclophosphamide and total body irradiation \[TBI\]) followed by hematopoietic stem cell transplant (HSCT). The study will evaluate the safety and pharmacokinetics of palifermin in pediatric patients. Three doses (40 μg/kg/day, 60 μg/kg/day, and 80 μg/kg/day) are to be evaluated in each age group (1 to 2, 3 to 11, and 12 to 16 years, respectively) using a conventional dose escalation design. Palifermin is administered for 3 consecutive days (Day -10 to Day -8, respectively) before the start of the conditioning regimen and for 3 consecutive days (Day 0 to Day +2) following HSCT. Patients will be enrolled simultaneously to each age group to identify a safe, well tolerated, efficacious dose in each age group. Patients will also be followed for secondary malignancies, progression-free survival (PFS) and overall survival (OS)
Study Details
Timeline
Interventions
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).
High dose etoposide, Cyclophosphamide