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| Sponsored by: |
Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00109031 |
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 III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | February 2011 |
| 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
|
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
|
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 and placebo on the 3 days prior to fTBI and palifermin 60 mcg/kg on days 0, 1 and 2
|
Drug: palifermin
palifermin 60 mcg/kg and placebo 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
|
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 |
Inclusion Criteria: - 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 106 CD34+ cells/kg cryopreserved and to be transplanted. Exclusion Criteria: - Cancer other than those specified in inclusion criteria 4.1.1 (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
| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20040212 |
| Study First Received: | April 22, 2005 |
| Last Updated: | February 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00109031 |
| Health Authority: | United States: Food and Drug Administration |
|
Cancer Oncology |
|
Mouth Diseases Lymphatic Diseases Leukemia Immunoproliferative Disorders Stomatitis |
Mucositis Stomatognathic Diseases Lymphoproliferative Disorders Lymphoma |
|
Neoplasms Neoplasms by Histologic Type Immune System Diseases |
