Conditions: Cancer Lymphoma Leukemia
Keywords: Cancer Oncology
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 47
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Palifermin 60 µg/kg plus placebo to match the total volume equivalent to a 180 µg/kg dose on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC). Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0. arm 2: Palifermin 180 μg/kg on Day -1 and matched placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0. arm 3: Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0. arm 4: Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.

Interventions: intervention 1: palifermin intervention 2: Total Body Irradiation intervention 3: Cyclophosphamide intervention 4: Etoposide intervention 5: Placebo
Intervention descriptions: intervention 1: Administered as one daily intravenous bolus. intervention 2: To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days. intervention 3: Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2 intervention 4: Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction. intervention 5: Administered as one daily intravenous bolus.

Protocol document: