Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248365
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2005-11-03
Brief Title:
Theralux Extracorporeal Photochemotherapy ECP in Patients With Extensive Chronic Graft Versus Host Disease GvHD
Sponsor:
Kiadis Pharma
Organization:
Kiadis Pharma
Study Overview
Official Title:
Safety Biological and Clinical Efficacy of Two Intensity Levels of Theralux Extracorporeal Photochemotherapy in Subjects With Extensive Chronic GvHD Refractory or Intolerant to Standard Therapy A Randomized Open-label Phase III Clinical Trial
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the tolerability and safety of two intensity levels of Theralux extracorporeal photochemotherapy in the treatment of subjects with steroid refractory or intolerant GvHD
The current hypothesis is that apoptotic cells re-injected into patients induce an immunomodulation effect alleviating the GvHD symptoms Using the Theralux procedure the dose of photodynamic treatment may be modulated to achieve the maximal immunomodulatory effects in the treated patients
The intervention is iterative extracorporeal photochemotherapy of autologous peripheral blood mononuclear cells PBMC with a rhodamine-derivative TH9402 drug and Theralux device
The current hypothesis is that apoptotic cells re-injected into patients induce an immunomodulation effect alleviating the GvHD symptoms Using the Theralux procedure the dose of photodynamic treatment may be modulated to achieve the maximal immunomodulatory effects in the treated patients
The intervention is iterative extracorporeal photochemotherapy of autologous peripheral blood mononuclear cells PBMC with a rhodamine-derivative TH9402 drug and Theralux device
Detailed Description:
Graft versus host disease GvHD remains a major cause of morbidity and mortality related to allogeneic stem cell transplantation While improvements in immuno-suppressive regimens have reduced the frequency and severity of acute GvHD the incidence of chronic GvHD cGvHD remains unchanged ranging from 30 after sibling matched related donor transplants to over 70 after unrelated donor bone marrow or peripheral blood stem cell transplant Factors associated with cGvHD include increased donor and recipient age prior acute GvHD and the use of alloimmune female donors Conventional therapeutic approaches for cGvHD including corticosteroids and immunosuppressive agents have demonstrated limited efficacy in patients with extensive disease and are associated with high toxicity
Iterative extracorporeal photopheresis has demonstrated clinical and immunomodulatory activity in subjects with acute and chronic GvHD The currently available process of ECP has not been controlled for cell number exposure time or specific cell populations targeted due to the nature of the procedure Using the Theralux procedure defined populations of cells may be targeted and the intensity of photoactivating agent and exposure can be modulated to achieve the maximal immunomodulatory effects in the treated subjects This study will attempt to explore the effects of the Theralux procedure under two defined conditions Response and toxicity will be determined at each intensity level and the dose associated with clinical response and immunomodulatory effects on DC and NK cell populations will be defined as the optimal intensity level for subsequent larger trials
Iterative extracorporeal photopheresis has demonstrated clinical and immunomodulatory activity in subjects with acute and chronic GvHD The currently available process of ECP has not been controlled for cell number exposure time or specific cell populations targeted due to the nature of the procedure Using the Theralux procedure defined populations of cells may be targeted and the intensity of photoactivating agent and exposure can be modulated to achieve the maximal immunomodulatory effects in the treated subjects This study will attempt to explore the effects of the Theralux procedure under two defined conditions Response and toxicity will be determined at each intensity level and the dose associated with clinical response and immunomodulatory effects on DC and NK cell populations will be defined as the optimal intensity level for subsequent larger trials
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