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
Overview
- Phase
- Early Phase 1
- Intervention
- extracorporeal photopheresis
- Conditions
- Stem Cell Leukemia of Unclear Lineage
- Sponsor
- University of Kansas Medical Center
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Presence/absence of grade II-IV acute Graft versus Host Disease (aGVHD)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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 unrelated BMT or PBSC transplant, for treatment of hematologic or lymphoproliferative malignancies.
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 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.
Investigators
Eligibility Criteria
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.
Exclusion Criteria
- Not provided
Arms & Interventions
Extracorporeal Photopheresis
Patients will receive 2 ECP treatments on day -10 and day -8 and then for two consecutive days every two weeks starting from post engraftment (ANC \> 500) up to day 90 (total of 10 treatments). This may be given as an outpatient procedure.
Intervention: extracorporeal photopheresis
Outcomes
Primary Outcomes
Presence/absence of grade II-IV acute Graft versus Host Disease (aGVHD)
Time Frame: 100 days after transplant
The primary efficacy variable is the presence/absence of grade II-IV acute GvHD within the first 100 days after transplantation
Secondary Outcomes
- proportion of patients who develop chronic Graft versus Host Disease (cGVHD) and experience relapse of primary disease.(365 days after transplantation)