Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441818
Status:
UNKNOWN
Last Update Posted:
2008-05-09
First Post:
2006-05-17
Brief Title:
Safety and Efficacy Study of TNX-650 to Treat Refractory Hodgkins Lymphoma
Sponsor:
Tanox
Organization:
Tanox
Study Overview
Official Title:
A Phase III Non-RandomizedMultiple-DoseDose Escalation Study of the Safety Pharmacokinetics Pharmacodynamics and Efficacy of TNX-650 in Patients With Refractory Hodgkins Lymphoma
Status:
UNKNOWN
Status Verified Date:
2007-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the safety and effectiveness of TNX-650 for Injection when administered to patients with refractory Hodgkins lymphoma
Detailed Description:
Hodgkins lymphoma HL is a lymphoid malignancy that accounts for approximately 7000 to 8000 new cancer cases per year in the United Sates It occurs with a bimodal age-incidence distribution peaking in the 15- to 30-year old and 50- to 60-year old age groups The pathological hallmark of the disease is the presence of malignant Reed Sternberg RS cells Reed-Sternberg cells are interspersed among a heterogeneous population of non-malignant reactive cells including T cells eosinophils neutrophils B lymphocytes plasma cells histiocytes fibroblasts and stromal cells
While more than 80 of patients will respond to initial radiotherapy or combination chemoradiotherapy some patients will experience early relapse after initial therapy or be refractory to first-line therapy These patients may be treated with second-line therapy which may include autologous bone marrow transplantation BMT Patients with HL who relapse after first- and second-line therapy or who are refractory to therapy with or without autologous BMT have a poor prognosis The long-term event-free survival rate in this patient group is less than 10 median survival is 16 months At present these patients have no treatment options other than investigational therapies
While more than 80 of patients will respond to initial radiotherapy or combination chemoradiotherapy some patients will experience early relapse after initial therapy or be refractory to first-line therapy These patients may be treated with second-line therapy which may include autologous bone marrow transplantation BMT Patients with HL who relapse after first- and second-line therapy or who are refractory to therapy with or without autologous BMT have a poor prognosis The long-term event-free survival rate in this patient group is less than 10 median survival is 16 months At present these patients have no treatment options other than investigational therapies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None