Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)
This study has been completed.
Sponsor:
Swedish Orphan Biovitrum
Collaborator:
Amgen
Information provided by (Responsible Party):
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT00109031
First received: April 22, 2005
Last updated: July 13, 2012
Last verified: July 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Lymphoma Leukemia |
Drug: palifermin Drug: Palifermin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Swedish Orphan Biovitrum:
Primary Outcome Measures:
- Includes incidence of severe oral mucositis (OM), duration of severe OM, Patient-reported outcome (PRO) daily assessments of mouth and throat soreness, use of parenteral or transdermal opioid analgesics [ Time Frame: Up to Day 28 ] [ Designated as safety issue: No ]
| Enrollment: | 47 |
| Study Start Date: | January 2005 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm C
palifermin 180 mcg/kg 2 days prior to fTBI and placebo the day before and after the 180 mcg/kg dose and palifermin 60 mcg/kg on days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC)
|
Drug: palifermin
palifermin 180 mcg/kg 2 days prior to fTBI and placebo the day before and after the 180 mcg/kg dose and palifermin 60 mcg/kg on days 0, 1 and 2
|
|
Arm D
palifermin 180 mcg/kg 3 days prior to fTBI and placebo the 2 days after the 180 mcg/kg dose and palifermin 60 mcg/kg on days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC)
|
Drug: palifermin
palifermin 180 mcg/kg 3 days prior to fTBI and placebo the 2 days after the 180 mcg/kg dose and palifermin 60 mcg/kg on days 0, 1 and 2
|
|
Arm A
palifermin 60 mcg/kg on the 3 days prior to fTBI and palifermin 60 mcg/kg on days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC)
|
Drug: palifermin
palifermin 60 mcg/kg on the 3 days prior to fTBI and palifermin 60 mcg/kg on days 0, 1 and 2
|
|
Arm B
palifermin 180 mcg/kg 1 day prior to fTBI and placebo on the 2 days prior to the 180 mcg/kg dose and palifermin 60 mcg mcg/kg on days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC)
|
Drug: Palifermin
palifermin 180 mcg/kg 1 day prior to fTBI and placebo on the 2 days prior to the 180 mcg/kg dose and palifermin 60 mcg mcg/kg on days 0, 1 and 2
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Written informed consent
- Subjects with: 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 x 10^6 CD34+ cells/kg cryopreserved and to be transplanted.
Exclusion Criteria:
- Cancer other than those specified in inclusion criteria above (except: adequately treated basal cell carcinoma of the skin)
- Prior bone marrow or peripheral blood stem cell transplantation - Negatively selected (purged) stem cell product - Current active infection or oral mucositis
- Congestive heart failure as defined by New York Heart Association class III or IV.
- History of or current diagnosis of pancreatitis
- Inadequate renal function (serum creatinine greater than 1.5x the upper limit of normal per the institutional guidelines)
- Inadequate liver function (direct bilirubin greater than 1.5x the upper limit of normal, AST greater than 3x upper limit of normal and/or ALT greater than 3x upper limit of normal per the institutional guidelines)
- Inadequate pulmonary function as measured by a corrected DLCO less than 50% of predicted.
- Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Swedish Orphan Biovitrum |
| ClinicalTrials.gov Identifier: | NCT00109031 History of Changes |
| Obsolete Identifiers: | NCT00126529, NCT00965692 |
| Other Study ID Numbers: | 20040212 |
| Study First Received: | April 22, 2005 |
| Last Updated: | July 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Swedish Orphan Biovitrum:
|
Cancer Oncology |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Stomatitis Mucositis Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Mouth Diseases Stomatognathic Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013