NCT01199562|Active Not RecruitingDMC

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

City of Hope Medical Center ClinicalTrials.gov

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2 other identifiers

09038NCI-2010-01932

Study Type

observational

Target

153

Locations

1 country

Sites

Timeline

RegisteredSep 2010

StartedDec 2010

CompletionDec 2026

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

153

participants targeted

Target at P50-P75 for all trials

Timeline

8mo left

Started Dec 2010

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

16 years study duration

Study Progress96%

Dec 2010Dec 2026

First Submitted

Initial submission to the registry

September 8, 2010

Completed

5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed

3 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2013

Completed

12.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

3.1 years

First QC Date

September 8, 2010

Last Update Submit

January 27, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

Initiation of anti-CMV therapy
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
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 Outcomes (2)

CMV reactivation-free survival, monitored using a real time PCR assay for CMV DNA in plasma
Up to day 100 post-transplant
Percent cytotoxicity and ex vivo percent CD56+/CD107B+ cells
Day 120 post stem cell transplant

Study Arms (1)

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.

Procedure: infection prophylaxis and managementOther: laboratory biomarker analysisOther: flow cytometryGenetic: DNA analysisGenetic: RNA analysisProcedure: management of therapy complicationsDrug: ganciclovirDrug: valganciclovirDrug: foscarnet sodiumProcedure: antiviral therapyGenetic: polymerase chain reactionGenetic: protein expression analysis

Interventions

flow cytometryOTHER

Correlative studies

Arm I

infection prophylaxis and managementPROCEDURE

Undergo infection prophylaxis and management

Also known as: treatment of infectious disease

Arm I

laboratory biomarker analysisOTHER

Correlative studies

Arm I

DNA analysisGENETIC

Correlative studies

Arm I

RNA analysisGENETIC

Correlative studies

Arm I

management of therapy complicationsPROCEDURE

undergo infection prophylaxis and management

Also known as: complications of therapy, management of

Arm I

ganciclovirDRUG

Given IV

Also known as: BW 759U, BW-B759U

Arm I

valganciclovirDRUG

Given orally

Also known as: Valcyte, VGCV

Arm I

foscarnet sodiumDRUG

Given orally

Also known as: Foscavir, trisodium phosphonoformate

Arm I

antiviral therapyPROCEDURE

undergo infection prophylaxis and management

Also known as: therapy, antiviral

Arm I

polymerase chain reactionGENETIC

Correlative studies

Also known as: PCR

Arm I

protein expression analysisGENETIC

Correlative studies

Arm I

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

City of Hope Medical Centerlead
National Cancer Institute (NCI)collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Hematologic NeoplasmsLeukemia, Myeloid, Accelerated PhaseLeukemia, Biphenotypic, AcuteCongenital AbnormalitiesLymphoma, Extranodal NK-T-CellLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyAnemia, AplasticLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisPdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Myelomonocytic, ChronicLeukemia, Neutrophilic, ChronicLeukemia, Myeloid, Chronic-PhaseCytomegalovirus InfectionsThrombocythemia, EssentialIntraocular LymphomaLeukemia, Mast-CellMyeloproliferative DisordersLymphoma, B-Cell, Marginal ZonePolycythemia VeraPrimary MyelofibrosisImmunoglobulin Light-chain AmyloidosisLeukemia, ProlymphocyticPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellMultiple MyelomaLeukemia, Large Granular LymphocyticWaldenstrom Macroglobulinemia

Interventions

TherapeuticsFlow CytometryGanciclovirValganciclovirFoscarnetAntiviral AgentsPolymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLymphoma, T-CellLymphomaLymphadenopathyAnemiaBone Marrow Failure DisordersMyelodysplastic-Myeloproliferative DiseasesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersHemorrhagic DisordersEye NeoplasmsMastocytosis, SystemicMastocytosisMast Cell Activation DisordersLymphoma, B-CellBone Marrow NeoplasmsNeoplasms, Plasma CellAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesParaproteinemiasEpstein-Barr Virus InfectionsTumor Virus InfectionsLeukemia, B-CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesBlood Protein DisordersLeukemia, T-Cell

Intervention Hierarchy (Ancestors)

Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesAcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhosphonoacetic AcidAcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsOrganophosphonatesOrganophosphorus CompoundsAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesNucleic Acid Amplification TechniquesGenetic Techniques

Study Officials

Ryotaro Nakamura
City of Hope Medical Center
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 8, 2010

First Posted

September 13, 2010

Study Start

December 1, 2010

Primary Completion

December 30, 2013

Study Completion (Estimated)

December 1, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (1)

Arm I

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations