CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 47 enrolled
Drug / intervention
palifermin +4 moredrug
Likely dose
Palifermin administered as one daily intravenous bolus; cyclophosphamide 100 mg/kg total dose on Day -2; etoposide optional as single IV infusion over 4 hours on day after last fTBI fractionAI-extracted
Key inclusion· 2
  • ✓Diagnosis of non-Hodgkin's lymphoma, Hodgkin's disease, acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, or multiple myeloma
  • ✓Minimum of 1.5 × 10^6 CD34+ cells/kg cryopreserved for transplantation
Key exclusion· 7
  • ✕Prior bone marrow or peripheral blood stem cell transplantation
  • ✕Negatively selected (purged) stem cell product
  • ✕Current active infection or oral mucositis
  • ✕Congestive heart failure NYHA class III or IV

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00109031
NCT00109031Phase 3Completed
CompareCT.gov

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

Swedish Orphan Biovitrum·interventional·Posted Apr 25, 2005·Updated Sep 15, 2014

In Brief

A Phase 3 clinical trial evaluating palifermin, Total Body Irradiation, and 3 other interventions for Cancer and 2 related conditions. Completed, enrolled 47 participants.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer, Lymphoma, Leukemia
Countries--
CollaboratorsAmgen

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 25, 2005
Enrollment StartJan 1, 2005
Primary CompletionFeb 1, 2006
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 21.2 years ago

Interventions

palifermindrug

Administered as one daily intravenous bolus.

Total Body Irradiationradiation

To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.

Cyclophosphamidedrug

Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2

Etoposidedrug

Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.

Placebodrug

Administered as one daily intravenous bolus.