Status:
COMPLETED
Test Extracorporeal Photopheresis (ECP) Treatment Before/After Allogeneic Bone Marrow Transplant (BMT) or Peripheral Blood Stem Cell (PBSC) Transplant to Prevent Graft Versus Host Disease
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
Mallinckrodt
Conditions:
Stem Cell Leukemia of Unclear Lineage
Graft Versus Host Disease
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
To study the effect of ECP with Uvadex® in conjunction with a standard myeloablative conditioning regimen on the incidence of acute and chronic GvHD in patients undergoing an allogeneic related or unr...
Detailed Description
This study is to test the concept that using ECP treatment prior to and after an allogeneic bone marrow transplant (BMT) or peripheral blood stem cell (PBSC) transplant will prevent the development of...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients are eligible if they have a diagnosis of one of the following hematologic or lymphoproliferative malignancies for which a treatment option would be an allogeneic BMT or PBSC transplant:
- acute myelogenous leukemia
- chronic myelogenous leukemia
- acute lymphocytic/blastic leukemia
- chronic lymphocytic leukemia
- myelodysplastic syndrome
- non-Hodgkin's lymphoma (expected survival \> 60 days)
- Hodgkin's disease (expected survival \> 60 days)
- Patients who are candidates for a standard allogeneic BMT or patients who are candidates for a standard allogeneic PBSC transplant.
- Patients must have a suitable HLA- molecular matched (8/10 or more) related or unrelated donor.
- Patients must be physically and psychologically capable of undergoing a BMT or PBSC transplant and the attendant period of strict isolation.
- Patients must test negative for human immunodeficiency virus (HIV).
- Patients must present no evidence of active ongoing infection.
- Patients must have adequate renal, hepatic, pulmonary, and cardiac function to enable the patient to tolerate the extracorporeal volume shifts associated with ECP, as determined by the physician's clinical judgment.
- Platelets ≥ 20,000/cmm.
- Patients ≥ 18 years of age.
- Weight ≥ 40 kg (88 lb).
- Systolic Blood Pressure ≥ 90 mm Hg after the patient has been in a sitting position for five minutes.
- Women of childbearing potential must agree to use a reliable method of birth control for the duration of the study.
- Patients must be willing to comply with all study procedures.
- Signed and dated informed consent must be obtained prior to conducting any study procedures. The parent or legal guardian of a minor must also provide written informed consent.
- Exclusion Criteria
- Patients who have received a prior allogeneic BMT or PBSC transplant.
- Hypersensitivity or allergy to psoralen (methoxsalen).
- Contraindication to radiation, cyclophosphamide, CSA, Busulphan or MTX.
- Hypersensitivity or allergy to both heparin and citrate products. (If hypersensitive or allergic to only one of these two products, exclusion does not apply if the other product is strictly used for the patient.)
- Patients whose treatment requires donor lymphocyte infusion up to day 100 post-transplant.
- Participation in another clinical trial for prevention of GvHD within 7 days prior to patient enrollment or concurrent participation in any other clinical study.
- Active gastrointestinal bleeding.
- Females who are pregnant or lactating.
- Previous treatment with ECP.
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01174940
Start Date
June 1 2010
End Date
August 1 2015
Last Update
January 9 2017
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160