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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Cancer, Lymphoma, Leukemia

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

Up to Day 28

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20040212

NCT ID:

NCT00109031

Start Date:

January 2005

Completion Date:

December 2010

Related Keywords:

  • Cancer
  • Lymphoma
  • Leukemia
  • Cancer
  • Oncology
  • Leukemia
  • Lymphoma
  • Stomatitis
  • Mucositis

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