Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant

• Initiation of anti-CMV therapy [ Time Frame: Day 80 post stem cell transplant ] [ Designated as safety issue: No ]
  
• Diagnosis of CMV pneumonia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  

• CMV disease, morbidity, and mortality [ Time Frame: Through 1 year ] [ Designated as safety issue: No ]
  
• Efficacy of an individualized strategy for CMV preemptive management on incidence of CMV disease, specifically CMV pneumonia [ Time Frame: By day 100 post transplant ] [ Designated as safety issue: No ]
  
• CMV reaction-free survival [ Time Frame: Post-transplant days 21 - 100 ] [ Designated as safety issue: No ]
  
• Percent cytotoxicity and ex vivo percent CD56+/CD107B+ cells [ Time Frame: Day 120 post stem cell transplant ] [ Designated as safety issue: No ]
  

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.