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
Stem Cell Leukemia of Unclear Lineage
Graft Versus Host Disease
Drug: extracorporeal photopheresis
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Presence/absence of grade II-IV acute Graft versus Host Disease (aGVHD) [ Time Frame: 100 days after transplant ] [ Designated as safety issue: Yes ]The primary efficacy variable is the presence/absence of grade II-IV acute GvHD within the first 100 days after transplantation
- proportion of patients who develop chronic Graft versus Host Disease (cGVHD) and experience relapse of primary disease. [ Time Frame: 365 days after transplantation ] [ Designated as safety issue: Yes ]
These secondary efficacy variables for a patient are dichotomous:
- the development of cGvHD during 365 days after transplantation (and which body sites are involved)
- the relapse of primary disease (hematologic or lymphoproliferative malignancy)
- the grade of aGvHD
- the involved sites of cGvHD
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: 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.
Drug: extracorporeal photopheresis
Patients will receive 2 ECP treatments prior to the commencement of the high dose chemotherapy 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.
The dose of UVADEX® used to inoculate these cells will be calculated based on the treatment volume collected during the plasma/buffy coat collection process, using the following formula:
Treatment Volume in mL X 0.017 of UVADEX® (20 mcg/ml) required for administration into the recirculation bag = Amount of UVADEX® (in mLs) required for administration into the recirculation bag.
After the cells are inoculated with UVADEX®, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then re-infused back into the patient.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174940
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Sunil Abhyankar, MD||University of Kansas Medical Center|