CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 155 enrolled
Drug / intervention
Palifermin +4 moredrug
Likely dose
Palifermin administered as intravenous bolus (specific dose not stated in interventions)AI-extracted
Key inclusion· 4
  • ✓Hematologic malignancies (NHL, Hodgkin's, AML, ALL, CML, CLL, MDS, or multiple myeloma) eligible for standard allogeneic stem cell transplantation with specified conditioning regimens
  • ✓6/6 HLA-matched family member or unrelated donor available (molecular typing of class I and II required for unrelated donors)
  • ✓Karnofsky Performance Status ≥70%
  • ✓Age 18 years or older
Key exclusion· 11
  • ✕Malignancies other than NHL, Hodgkin's, AML, ALL, CML, CLL, MDS, or multiple myeloma (except adequately treated basal cell carcinoma)
  • ✕Prior autologous or allogeneic bone marrow or peripheral blood stem cell transplantation
  • ✕Previous use of palifermin
  • ✕Current active infection (including HIV and hepatitis) or oral mucositis

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

Search/NCT00189488
NCT00189488Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled Trial to Evaluate Palifermin (rHuKGF) in the Reduction of Acute Graft Versus Host Disease in Subjects With Hematologic Malignancies Undergoing Allogeneic Marrow/PBPC Transplantation

Swedish Orphan Biovitrum·interventional·Posted Sep 19, 2005·Updated Sep 15, 2014

In Brief

A Phase 2 clinical trial evaluating Palifermin, Placebo, and 3 other interventions for Graft Versus Host Disease and Hematologic Malignancies. Completed, enrolled 155 participants.

Detailed Summary

The main purpose of this study is to evaluate the effect of palifermin versus placebo in the reduction of severe acute graft versus host disease (GVHD) and severe oral mucositis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft Versus Host Disease, Hematologic Malignancies
Countries--
CollaboratorsAmgen

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartDec 1, 2005
Primary CompletionNov 1, 2008
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.8 years ago

Interventions

Palifermindrug

Administered as an intravenous (IV) bolus.

Placebodrug

Administered as an intravenous (IV) bolus.

Conditioning Regimenother

Each participant received 1 of the following conditioning regimens: * Cyclophosphamide (Cy) / total body irradiation (TBI) with and without etoposide (VP-16) * TBI/VP-16 * Melphalan (Mel)/TBI (TBI regimens must include fully ablative doses ie \> 1100 cGy; sequence of chemotherapy/radiation (CT/RT) flexible) * Busulfan (Bu)/Cy * Bu/Mel (non-TBI but fully ablative regimens/doses \[Mel dose \> 140 mg/m\^2\]) * Fludarabine (Flu)/Mel (non-TBI but fully ablative regimens/doses \[Mel dose \> 140 mg/m\^2\])

Allogeneic stem cell transplantprocedure

Allogeneic marrow/peripheral blood progenitor cell transplantation

Methotrexatedrug