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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00248365
Recruitment Status : Completed
First Posted : November 4, 2005
Last Update Posted : February 25, 2016
Information provided by:
Kiadis Pharma

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).

Condition or disease Intervention/treatment Phase
Graft vs Host Disease Biological: Theralux extracorporeal photochemotherapy Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2005
Actual Study Completion Date : August 2007

Arm Intervention/treatment
Experimental: Low PDT intensity level
Theralux extracorporeal photochemotherapy PDT dose: TH9402 0.33μM
Biological: Theralux extracorporeal photochemotherapy
Experimental: High PDT intensity level
Theralux extracorporeal photochemotherapy PDT dose: TH9402 1.32μM
Biological: Theralux extracorporeal photochemotherapy

Primary Outcome Measures :
  1. Signs of toxicity
  2. Chronic GvHD grading
  3. Dose of immunosuppressive medications

Secondary Outcome Measures :
  1. ECOG Performance
  2. Survival
  3. Immunomodulatory and Biological effects

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00248365

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

Additional Information: Identifier: NCT00248365     History of Changes
Other Study ID Numbers: CR-ECP-001
First Posted: November 4, 2005    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016

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

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