Pentostatin and Donor Lymphocyte Infusion for Low Donor T-Cell Chimerism After Hematopoietic Cell Transplantation - A Multi-Center Trial
I. To assess the safety and efficacy of the combined use of pentostatin and donor lymphocyte
infusion (DLI) in patients with low or falling donor T-cell chimerism to prevent graft
rejection after transplantation both from matched related donors (MRDs) or unrelated donors
I. To determine the incidence of graft-versus-host disease (GvHD) infections, and disease
response (if persistent disease is present).
OUTLINE: This is a dose-escalation study of donor lymphocyte infusion. Patients are assigned
to 1 of 2 treatment groups.
GROUP I: Patients receive pentostatin intravenously (IV) over 20-30 minutes on day -2 and
DLI over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or
same cluster of differentiation (CD)3-dose at least 4 weeks if persistent donor T-cells are
documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status
is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
GROUP II (initiated if patients in group I do not achieve sustained engraftment and improved
chimerism): Patients receive treatment as in group I. Patients also receive cyclosporine
orally (PO) twice daily on days -3 to 56 and mycophenolate mofetil PO once daily on days 0
to 27. Treatment continues in the absence of GvHD.
After completion of study treatment, patients are followed up every 6 months for 2 years and
then annually thereafter.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of the combined use of pentostatin and DLI as defined by an acceptable rate of grade IV acute GVHD
Reported following the Fred Hutchinson Cancer Research Center (FHCRC) Guidelines for serious adverse event (SAE) reporting.
Within 100 days after the last DLI
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|LDS Hospital||Salt Lake City, Utah 84143|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|VA Puget Sound Health Care System||Seattle, Washington 98101|
|Huntsman Cancer Institute/University of Utah||Salt Lake City, Utah 84112|