Modified Pre-emptive CMV Management Strategy After Allogeneic Hematopoietic Cell Transplantation and Laboratory Correlation With Innate Immune Function
PRIMARY OBJECTIVES:
I. To evaluate the efficacy and safety of a individualized strategy for CMV preemptive
management, one that monitors CMV viral load and clinical markers of immunosuppression to
optimize use of ganciclovir in recipients of allogeneic HCT (Hematopoietic Cell Transplant)
who experience CMV reactivation.
SECONDARY OBJECTIVES:
I. To investigate how donor Killer Immunoglobulin-like Receptor (KIR) genes of interest
(activating KIR2DS2 and 2DS4, inhibitory KIR2DL1, 2DL2/2DL3, 3DL1, 3DL2), together with
their recipient ligands where known, influence CMV reactivation-free survival after
allogeneic HCT, independently of clinical risk factors such as onset of acute
graft-versus-host disease. II. To investigate whether markers of Natural Killer (NK) cell
function correlate with a) KIR/ligand compound genotype and baseline or concurrent clinical
factors and b) with history of CMV reactivation and anti-CMV therapy at the time of NK cell
collection.
OUTLINE:
Patients receive standard antiviral infection prophylaxis and management comprising
ganciclovir (GCV), valganciclovir, or foscarnet sodium for 2 weeks or until the plasma CMV
DNA Q-PCR is negative. Patients may receive additional courses based on subsequent CMV
reactivations. After completion of study treatment, patients are followed up periodically.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Initiation of anti-CMV therapy
Day 80 post stem cell transplant
No
Ryotaro Nakamura
Principal Investigator
City of Hope Medical Center
United States: Institutional Review Board
09038
NCT01199562
December 2010
Name | Location |
---|---|
City of Hope Medical Center | Duarte, California 91010 |