Conditioning for Graft Failure After Hematopoietic Stem Cell Transplantation
- To determine the rate of sustained donor engraftment at 42 days and survival at 100
days post transplantation in patients treated with anti-thymocyte globulin,
clofarabine, and rituximab.
- To determine incidence of treatment-related mortality at day 100 post transplantation.
- To determine incidence of neutrophil recovery by day 42 post transplantation.
- To determine survival at day 100 and 1 year post transplantation.
- To determine the proportion of patients with chimerism at day 28 post transplantation.
- To determine incidence and severity of grades II-IV acute graft-vs-host disease by day
100 post transplantation.
- Conditioning regimen: Patients receive rituximab intravenously (IV) on day -7,
anti-thymocyte globulin IV over 4-6 hours on days -6 to -4, and clofarabine IV over 1
hour on days -4 to -2.
- Hematopoietic stem cell transplantation (HSCT): Patients undergo HSCT on day 0.
Patients may receive umbilical cord blood, peripheral blood stem cells, or bone marrow
from unrelated or related donors.
- Graft-vs-host disease (GVHD) prophylaxis: Patients receive oral cyclosporine twice
daily or cyclosporine IV every 8 hours beginning on day -3 and continuing for 100 or
180 days post transplantation followed by a taper; mycophenolate mofetil IV every 8
hours beginning on day -3 and continuing for 30 days (or 7 days after engraftment with
no evidence of GVHD); and filgrastim (G-CSF) IV once daily beginning on day 1 and
continuing until blood counts recover.
After completion of study therapy, patients are followed on days 100, 180, and 360.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The process of transplanted stem cells reproducing new cells.
at 42 days post transplantation
Jakub Tolar, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|