Photopheresis for the Treatment of Acute Graft Versus Host Disease

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Mallinckrodt
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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%