NCT00248365

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

First QC Date

November 3, 2005

Last Update Submit

February 24, 2016

Conditions

Graft vs Host Disease

Keywords

Chronic GvHDExtensive chronic GvHDResistant chronic GvHD

Outcome Measures

Primary Outcomes (3)

  • Signs of toxicity

  • Chronic GvHD grading

  • Dose of immunosuppressive medications

Secondary Outcomes (3)

  • ECOG Performance

  • Survival

  • Immunomodulatory and Biological effects

Study Arms (2)

Low PDT intensity level

EXPERIMENTAL

Theralux extracorporeal photochemotherapy PDT dose: TH9402 0.33μM

Biological: Theralux extracorporeal photochemotherapy

High PDT intensity level

EXPERIMENTAL

Theralux extracorporeal photochemotherapy PDT dose: TH9402 1.32μM

Biological: Theralux extracorporeal photochemotherapy

Interventions

Theralux extracorporeal photochemotherapyBIOLOGICAL
High PDT intensity levelLow PDT intensity level

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

B.C. Cancer Research Center

Vancouver, British Columbia, V5Z 1L3, Canada

Location

McMaster University Medical Center

Hamilton, Ontario, L8N 3Z5, Canada

Location

Ottawa General Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Related Links

MeSH Terms

Conditions

Graft vs Host DiseaseBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Immune System DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 4, 2005

Study Start

November 1, 2005

Study Completion

August 1, 2007

Last Updated

February 25, 2016

Record last verified: 2016-02

Locations

CA(4)