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

January 27, 2026 updated by: City of Hope Medical Center

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis: hematologic malignancies/disorders including aplastic anemia and myelodysplastic syndrome
  • Procedure: first allogeneic, T cell-replete transplantation of stem-cells from peripheral blood or bone marrow of an human leukocyte antigen (HLA) matched, unrelated or nonsyngeneic sibling donor
  • CMV seropositive donor and/or recipient
  • Performance level: must have already been determined to be eligible for HCT at City of Hope (COH)
  • Organ function requirements: The minimum organ function requirements should be the same as the requirements for HCT
  • Informed Consent: All patients must be capable of signing a written informed consent and no consent can be provided by a legal guardian

Exclusion Criteria:

  • The recipient had prior polymerase chain reaction (PCR) positive CMV infection in blood or organ-specific disease in the past 12 months
  • The source of hematopoietic stem cells is T-cell depleted
  • Concomitant anti-graft-versus-host disease (GVD) treatment includes in vivo T cell depletion
  • Recipient is human immunodeficiency virus (HIV)-1 positive
  • No prior allogeneic HCT (Allo HCT) (autologous HCT [Auto HCT] is allowed)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arm I
Patients receive standard antiviral infection prophylaxis and management comprising ganciclovir, 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.
Other: laboratory biomarker analysis
Correlative studies
Other: flow cytometry
Correlative studies
Genetic: polymerase chain reaction
Correlative studies
Other Names:
  • PCR
Genetic: DNA analysis
Correlative studies
Genetic: RNA analysis
Correlative studies
Procedure: infection prophylaxis and management
Undergo infection prophylaxis and management
Other Names:
  • treatment of infectious disease
Procedure: management of therapy complications
undergo infection prophylaxis and management
Other Names:
  • complications of therapy, management of
Drug: ganciclovir
Given IV
Other Names:
  • BW 759U
  • BW-B759U
Drug: valganciclovir
Given orally
Other Names:
  • Valcyte
  • VGCV
Drug: foscarnet sodium
Given orally
Other Names:
  • Foscavir
  • trisodium phosphonoformate
Procedure: antiviral therapy
undergo infection prophylaxis and management
Other Names:
  • therapy, antiviral
Genetic: protein expression analysis
Correlative studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initiation of anti-CMV therapy
Time Frame: Day 80 post stem cell transplant
Subjects will not be considered treated with anti-CMV agents unless at least 4 consecutive days of therapy are completed.
Day 80 post stem cell transplant
Diagnosis of CMV pneumonia
Time Frame: 1 year
Confirmed by detection of CMV in bronchoalveolar lavage or lung biopsy. Reported overall and separately for those whose preemptive management was and was not modified (postponed or foregone or limited to a false start) and compared to corresponding incidence in a similar cohort at our institution.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CMV reactivation-free survival, monitored using a real time PCR assay for CMV DNA in plasma
Time Frame: Up to day 100 post-transplant
Modeled using proportional hazards regression. Primary risk factors will be donor KIR of interest (activating KIR2DS2 and 2DS4, inhibitory KIR2DL1, 2DL2/2DL3, 3DL1, 3DL2), together with their recipient ligands where known. Potential confounding factors to be controlled in the model will include established clinical risk factors, including pretransplant CMV serostatus of donor and recipient, unrelated donor, marrow versus peripheral blood stem cells, and onset of acute graft-versus-host disease, handled as a time-dependent variable. The proportionality of hazards over time will be verified.
Up to day 100 post-transplant
Percent cytotoxicity and ex vivo percent CD56+/CD107B+ cells
Time Frame: Day 120 post stem cell transplant
Studied longitudinally in generalized linear models. Each of the 2 markers of NK function will be modeled separately.
Day 120 post stem cell transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Ryotaro Nakamura, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

December 30, 2013

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 10, 2010

First Posted (Estimated)

September 13, 2010

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09038
  • NCI-2010-01932

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Myelofibrosis

Clinical Trials on laboratory biomarker analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe