Photopheresis for the Treatment of Acute Graft Versus Host Disease
Condition: Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Intervention: Photopheresis; Methylprednisolone
Intervention description: 8-9 photopheresis treatments weekly for days 1-14, 6 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60. After day 60, your doctor will decide whether ECP is worth continuing, and the frequency of treatments.; 2 mg/kg daily with a taper to no less than 1 mg/kg/day by day 14, followed by a tapering schedule according to the suggested guidelines.
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Healthy volunteers: No
Keywords: Allogeneic stem cell grafts; Allogeneic bone marrow graft; Blood and Marrow Transplantation; Stem cell graft; Graft Versus Host Disease; GVHD; Extracorporeal Photopheresis; ECP; Photopheresis; Methylprednisolone; Medrol; Depo-Medrol; Solu-Medrol

Summary:

      The goal of this clinical research study is to find out whether adding extracorporeal
      photopheresis (ECP) to standard therapy for acute GVHD with corticosteroids improves response
      to treatment, length of treatment, and survival.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must be recipients of allogeneic bone marrow or stem cell grafts.

          2. Patient must weigh above 40 kg

          3. Patients must have new onset, clinical grade II-III acute or late-acute GVHD of the GI
             tract or liver, or the skin that developed post transplantation. The diagnosis of GVHD
             must be pathologically confirmed in at least one organ or highly suspected clinically.
             Pathological confirmation may occur after registration and after the start of therapy.
             Definition of Late Acute GVHD vs Acute GVHD: The diagnosis of Late Acute GVHD includes
             clinical features that are identical to Acute GVHD, however, Late Acute GVHD is
             diagnosed on or after day 100 post transplantation.

          4. Continued from #3: These manifestations include a maculopapular rash, abnormal liver
             studies (cholestatic jaundice) and/or nausea/vomiting / diarrhea. Patients must not
             have any concurrent classical features of chronic GVHD in addition to the above
             manifestations. Features of chronic GVHD include dry eyes and mouth, contractures,
             and/ or sclerodermal, lichenoid skin changes.

          5. In the clinical judgment of the PI, patients must be able to sustain a platelet count
             and a hematocrit >/= 20,000/mL and >/= 27% respectively, with or without transfusions.

          6. The absolute white blood cell count (WBC) must be >1500/mL

          7. Patient must be willing to comply with all study procedures.

          8. All patients with childbearing potential, including males and females, must commit to
             using adequate contraceptive precautions throughout their participation in the study
             and for 3 months following the last ECP treatment.

        Exclusion Criteria:

          1. Patients developing chronic GVHD following immune modulation with immunosuppression
             withdrawal or donor lymphocyte infusion (DLI).

          2. Any clinical Manifestation consistent with de novo chronic GVHD or overlapped syndrome
             of acute and chronic GVHD.

          3. Patients who are unable to tolerate the volume shifts associated with ECP treatment
             due to the presence of any of the following conditions: uncompensated congestive heart
             failure, pulmonary edema, severe asthma or chronic obstructive pulmonary disease,
             hepatorenal syndrome.

          4. Active bleeding

          5. International normalized ration (INR) >2

          6. Patients cannot have received methylprednisolone > 2mg/kg/day for more than 72 hours
             prior to registration.

          7. Patients cannot have received any other immunosuppression for treatment of GVHD but
             calcineurin inhibitors and corticosteroids. Patients are allowed to have had any GVHD
             prophylaxis with the exception of ECP

          8. Patients with known hypersensitivity or allergy to psoralen

          9. Patients with known hypersensitivity or allergy to both citrate and heparin

         10. Patients with co-existing photosensitive disease (e.g. porphyria, systemic lupus
             erythematosus, albinism) or coagulation disorders.

         11. Uncontrolled, persistent hypertriglyceridemia, with levels > 800 mg%