RITUXIMAB FOR PREVENTION OF ACUTE GRAFT-VERSUS-HOST DISEASE (GVHD) AFTER UNRELATED DONOR ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION (HCT)
PRIMARY OBJECTIVES:
I. To determine the incidence of grade II-IV acute GVHD at day 100 after matched unrelated
donor allogeneic hematopoietic cell transplantation (HCT) when incorporating rituximab in
the conditioning regimen.
SECONDARY OBJECTIVES:
I. To determine the day 100 transplant related mortality after matched unrelated donor
allogeneic HCT when incorporating rituximab in the conditioning regimen.
II. To determine overall survival (OS) and disease-free survival (DFS) after matched
unrelated donor allogeneic HCT when incorporating rituximab in the conditioning regimen.
III. To determine the cumulative incidence of infectious complications at day 100 after
matched unrelated donor HCT when incorporating rituximab in the conditioning regimen.
IV. To determine the effect of rituximab addition to the conditioning regimen on recovery of
T regulatory (T-reg) cells, and to determine the effect of T-cell, including T-reg, number
in the stem cell product and at day 30 on the incidence of grade II-IV acute GVHD (aGVHD)
and the cumulative infectious complications at day 100.
V. To determine the effect of rituximab addition to the conditioning regimen on antigen
presenting myeloid cell recovery, and to determine the effect of dendritic cell subset DC1,
DC2 and myeloid-derived suppressor cells (MDSC), number in the stem cell graft and at day
+30 on the incidence of acute GVHD grade II-IV and the cumulative incidence of infectious
complications at day 100.
OUTLINE:
CONDITIONING REGIMEN: Patients receive one of the following conditioning regimens as per the
transplant physician: cyclophosphamide and total-body irradiation (TBI); targeted busulfan
and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive rituximab intravenously (IV) on days
-6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Patients
also receive tacrolimus IV continuously and then orally (PO) beginning on day -1 and
continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or
IV twice daily on days -1 to 60.
TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day
0.
Patients are followed up periodically for 100 days after transplant.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of grades II-IV acute GVHD
Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria.
At day 100
No
Robert Bociek
Principal Investigator
University of Nebraska
United States: Food and Drug Administration
083-09
NCT01044745
December 2009
Name | Location |
---|---|
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |