Theralux Extracorporeal Photochemotherapy (ECP) in Patients With Extensive Chronic Graft Versus Host Disease (GvHD)

This study has been completed.
Sponsor:
Information provided by:
Kiadis Pharma
ClinicalTrials.gov Identifier:
NCT00248365
First received: November 3, 2005
Last updated: January 24, 2008
Last verified: January 2008
  Purpose

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).


Condition Intervention Phase
Graft vs Host Disease
Procedure: Theralux extracorporeal photochemotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 I/II Clinical Trial

Resource links provided by NLM:


Further study details as provided by Kiadis Pharma:

Primary Outcome Measures:
  • Signs of toxicity
  • Chronic GvHD grading
  • Dose of immunosuppressive medications

Secondary Outcome Measures:
  • ECOG Performance
  • Survival
  • Immunomodulatory and Biological effects

Enrollment: 20
Study Start Date: November 2005
Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical features compatible with extensive chronic GvHD
  • Refractory or intolerant to standard therapy

Exclusion Criteria:

  • Pregnant or lactating women
  • Underlying concurrent medical condition which would hinder the ability to safely administer the treatment
  • Known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Participation to another investigational trial within 30 days of study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248365

Locations
Canada, British Columbia
B.C. Cancer Research Center
Vancouver, British Columbia, Canada, V5Z 1L3
Canada, Ontario
McMaster University Medical Center
Hamilton, Ontario, Canada, L8N 3Z5
Ottawa General Hospital
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Kiadis Pharma
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00248365     History of Changes
Other Study ID Numbers: CR-ECP-001
Study First Received: November 3, 2005
Last Updated: January 24, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Kiadis Pharma:
Chronic GvHD
Extensive chronic GvHD
Resistant chronic GvHD

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014