Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
Modified Preemptive CMV Management Strategy After Allogeneic Hematopoietic Cell Transplantation and Laboratory Correlation With Innate Immune Function
RATIONALE: Infection prophylaxis and management may help prevent cytomegalovirus (CMV)
infection caused by a stem cell transplant.
PURPOSE:This clinical trial studies infection prophylaxis and management in treating
cytomegalovirus infection in patients with hematologic malignancies previously treated with
donor stem cell transplant.
PRIMARY OBJECTIVES:
I. To evaluate the efficacy and safety of a individualized strategy for cytomegalovirus (CMV)
preemptive management, one that monitors CMV viral load and clinical markers of
immunosuppression to optimize use of ganciclovir in recipients of allogeneic hematopoietic
cell transplantation (HCT) who experience CMV reactivation.
SECONDARY OBJECTIVES:
I. To investigate how donor killer-cell immunoglobulin-like receptors (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.
III. To investigate associations between NK cell recovery and antigen-specific T cell immune
reconstruction.
OUTLINE: Patients receive standard antiviral infection prophylaxis and management comprising
ganciclovir, valganciclovir, or foscarnet sodium for 2 weeks or until the plasma CMV
deoxyribonucleic acid (DNA) quantitative polymerase chain reaction (Q-PCR) is negative.
Patients may receive additional courses based on subsequent CMV reactivations.
After completion of study treatment, patients are followed up for up to 1 year.
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