Trials / Active Not Recruiting

Active Not RecruitingNCT01199562

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

Modified Preemptive CMV Management Strategy After Allogeneic Hematopoietic Cell Transplantation and Laboratory Correlation With Innate Immune Function

Status: Active Not Recruiting
Phase: —
Study type: Observational
Enrollment: 153 (actual)

Sponsor: City of Hope Medical Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
PROCEDURE	infection prophylaxis and management	Undergo infection prophylaxis and management
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	flow cytometry	Correlative studies
GENETIC	DNA analysis	Correlative studies
GENETIC	RNA analysis	Correlative studies
PROCEDURE	management of therapy complications	undergo infection prophylaxis and management
DRUG	ganciclovir	Given IV
DRUG	valganciclovir	Given orally
DRUG	foscarnet sodium	Given orally
PROCEDURE	antiviral therapy	undergo infection prophylaxis and management
GENETIC	polymerase chain reaction	Correlative studies
GENETIC	protein expression analysis	Correlative studies

Timeline

Start date: 2010-12-01
Primary completion: 2013-12-30
Completion: 2026-12-01
First posted: 2010-09-13
Last updated: 2026-01-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01199562. Inclusion in this directory is not an endorsement.