Status:
COMPLETED
Photopheresis for the Treatment of Acute Graft Versus Host Disease
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Mallinckrodt
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
Phase:
PHASE2
Brief 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...
Detailed Description
ECP uses ultraviolet A radiation to treat lymphocytes. Although the exact reason why ECP may be beneficial is not completely understood, researchers believe that the lymphocytes treated this way are l...
Eligibility Criteria
Inclusion
- Patients must be recipients of allogeneic bone marrow or stem cell grafts.
- Patient must weigh above 40 kg
- 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.
- 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.
- 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.
- The absolute white blood cell count (WBC) must be \>1500/mL
- Patient must be willing to comply with all study procedures.
- 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
- Patients developing chronic GVHD following immune modulation with immunosuppression withdrawal or donor lymphocyte infusion (DLI).
- Any clinical Manifestation consistent with de novo chronic GVHD or overlapped syndrome of acute and chronic GVHD.
- 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.
- Active bleeding
- International normalized ration (INR) \>2
- Patients cannot have received methylprednisolone \> 2mg/kg/day for more than 72 hours prior to registration.
- 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
- Patients with known hypersensitivity or allergy to psoralen
- Patients with known hypersensitivity or allergy to both citrate and heparin
- Patients with co-existing photosensitive disease (e.g. porphyria, systemic lupus erythematosus, albinism) or coagulation disorders.
- Uncontrolled, persistent hypertriglyceridemia, with levels \> 800 mg%
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00609609
Start Date
January 1 2008
End Date
January 1 2016
Last Update
June 4 2018
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030