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A Study of Extracorporeal Photopheresis With UVADEX® in the Setting of a Standard Myeloablative Conditioning Regimen in Related or Unrelated Donor Hematopoietic Stem Cell Transplantation for the Prevention of Graft Versus Host Disease

Phase 0
18 Years
Open (Enrolling)
Stem Cell Leukemia of Unclear Lineage, Graft Versus Host Disease

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Trial Information

A Study of Extracorporeal Photopheresis With UVADEX® in the Setting of a Standard Myeloablative Conditioning Regimen in Related or Unrelated Donor Hematopoietic Stem Cell Transplantation for the Prevention of Graft Versus Host Disease

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 GvHD. This study is not designed to detect a specific treatment effect.
However, some statements about the outcome of the study are possible. A sample size of n =
21 patients could detect a statistically significant difference between the expected rate of
GvHD in an untreated population, 60%, and our hypothesized rate, 30%, for the
matched-unrelated recipients. This calculation is based on a one-sample, two-sided
chi-square test at the 5% level of significance with 80% power.

Patients will receive ECP from day -10 and day -8 before transplant and then from day of
engraftment absolute neutrophil count (ANC>500) until day 90 after transplant. Patients who
enter the study will receive a BMT or PBSC transplant from a donor who is matched unrelated
(8/10 to 10/10 match). Rates of acute GvHD and chronic GvHD that occur in patients are
50-70% for the matched-unrelated donor transplant.

The choice of sample size is 21 patients. The analysis will determine if there are favorable
trends for a treatment effect. Comparison on survival, and rates of acute and chronic GvHD
will be made with historical controls who have undergone similar myeloablative transplant
from an unrelated donor.

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

- 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Presence/absence of grade II-IV acute Graft versus Host Disease (aGVHD)

Outcome Description:

The primary efficacy variable is the presence/absence of grade II-IV acute GvHD within the first 100 days after transplantation

Outcome Time Frame:

100 days after transplant

Safety Issue:


Principal Investigator

Sunil Abhyankar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas


United States: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

October 2013

Related Keywords:

  • Stem Cell Leukemia of Unclear Lineage
  • Graft Versus Host Disease
  • myelogenous leukemia
  • lymphocytic leukemia
  • lymphoblastic leukemia
  • myelodysplastic syndrome
  • non-Hodgkin's lymphoma
  • Hodgkin's disease
  • Graft vs Host Disease
  • Leukemia
  • Leukemia, Myeloid, Acute



University of Kansas Medical Center Kansas City, Kansas  66160-7353