Modification of Extracorporeal Photopheresis in Cutaneous T-cell Lymphoma or Chronic Graft-versus-host Disease

Inclusion Criteria

• •Informed consent
• •cutaneous T-cell lymphoma (CTCL) (Mycosis fungoides and Sézary syndrome)
• •considered to respond inadequately to 8-MOP-ECP therapy. Inadequate response is defined as:
• •1. progressive disease: disease progression from baseline in skin score, blood or lymph nodes after 3-6 months or
• •2. stable disease: No- response after 3-6 months or
• •3. minimal response \< 50% (from baseline) reduction of skin scores and/or CD4/CD8 ratio or a loss of peripheral blood clone after 3-6 months.
• •(or) chronic graft-versus-host disease (cGvHD) and considered to respond inadequately to 8-MOP-ECP therapy. Chronic GvHD is defined as
• •1. presence of at least 1 clinical sign of cGvHD or
• •2. at least one distinct manifestation confirmed by pertinent biopsy or other relevant tests.
• •3. steroid dependence, intolerance or steroid refractoriness considered to respond inadequately to 8-MOP-ECP therapy with at least monthly intervals.
• •Inadequate response is defined as:
• •1. progression of cutaneous cGvHD defined as \>25% worsening from baseline as measured by the percent change in the total skin score or
• •2. after 3 months had an inadequate response of cutaneous cGvHD as defined by \<15% improvement in the total skin score compared with baseline, or a ≤25% reduction in corticosteroid dose.