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A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Recombinant Human Keratinocyte Growth Factor for Reduction of Mucositis in Patients With Hematologic Malignancies Undergoing Total Body Irradiation and High-dose Chemotherapy With Autologous PBPC Transplantation


Phase 3
18 Years
N/A
Not Enrolling
Both
Stomatitis

Thank you

Trial Information

A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Recombinant Human Keratinocyte Growth Factor for Reduction of Mucositis in Patients With Hematologic Malignancies Undergoing Total Body Irradiation and High-dose Chemotherapy With Autologous PBPC Transplantation


Inclusion Criteria:

* Patients with: non-Hodgkin's lymphoma, Hodgkin's disease, acute
myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic
lymphocytic leukemia, or multiple myeloma * Eligible for fractionated total body
irradiation (fTBI) plus high-dose chemotherapy followed by autologous PBPC support. * 18
years of age or older * Karnofsky performance status greater than or equal to 70% *
Minimum of 1.5 Mio CD34+ cells/kg cryopreserved and to be transplanted * Informed consent
for participation in the study Exclusion Criteria: * History of, or concurrent cancer
other than NHL, Hodgkin's disease, AML, ALL, CML, CLL, multiple myeloma * Prior bone
marrow or peripheral blood stem cell transplantation * Purged stem cell product *
Currently active infection or oral mucositis * Congestive heart failure * Serum creatinine
> 1.5x ULN * Direct bilirubin > 1.5x ULN * Transaminases > 3x ULN * Corrected DLCO < 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 is receiving other
investigational agent(s). * Subject is pregnant (eg, positive human chorionic gonadotropin
[HCG] test) or is breastfeeding. * Subject refuses to use adequate contraceptive
precautions. * Known hypersensitivity to any of the products to be administered during
dosing, including E coli-derived products. * Inability to give a truly informed consent.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20000162

NCT ID:

NCT00041665

Start Date:

Completion Date:

Related Keywords:

  • Stomatitis
  • Stomatitis
  • Mucositis
  • Hematologic Neoplasms

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