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Hematopoietic/Lymphoid CancerNCT01199562

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

An observational study of Hematopoietic/Lymphoid Cancer and Accelerated Phase Chronic Myelogenous Leukemia, run by City of Hope Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
infection prophylaxis and management, laboratory biomarker analysis and flow cytometry
How many people
153 participants
Where
1 siteUnited States
Study dates
11 Jan 2011to 1 Dec 2026
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
infection prophylaxis and management, laboratory biomarker analysis, flow cytometry, DNA analysis, RNA analysis
Medical subject headings
Hematologic Neoplasms, Leukemia, Myeloid, Accelerated Phase, Leukemia, Biphenotypic, Acute, Congenital Abnormalities, Lymphoma, Extranodal NK-T-Cell, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Anemia, Aplastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • infection prophylaxis and managementProcedure or surgery

    Also called treatment of infectious disease

    Undergo infection prophylaxis and management

  • laboratory biomarker analysisOther

    Correlative studies

  • flow cytometryOther

    Correlative studies

  • DNA analysisGenetic

    Correlative studies

  • RNA analysisGenetic

    Correlative studies

  • management of therapy complicationsProcedure or surgery

    Also called complications of therapy, management of

    undergo infection prophylaxis and management

  • ganciclovirDrug

    Also called BW 759U, BW-B759U

    Given IV

  • valganciclovirDrug

    Also called Valcyte, VGCV

    Given orally

  • foscarnet sodiumDrug

    Also called Foscavir, trisodium phosphonoformate

    Given orally

  • antiviral therapyProcedure or surgery

    Also called therapy, antiviral

    undergo infection prophylaxis and management

  • polymerase chain reactionGenetic

    Also called PCR

    Correlative studies

  • protein expression analysisGenetic

    Correlative studies

Study groups in NCT01199562
Study groupRoleWhat they receive
Arm IPatients 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.
Receives: Procedure: infection prophylaxis and management; Other: laboratory biomarker analysis; Other: flow cytometry; Genetic: DNA analysis; Genetic: RNA analysis; Procedure: management of therapy complications; Drug: ganciclovir; Drug: valganciclovir; Drug: foscarnet sodium; Procedure: antiviral therapy; Genetic: polymerase chain reaction; Genetic: protein expression analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 80 post stem cell transplant

  2. 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.

    Measured: 1 year

Secondary outcomes (2)

  1. CMV reactivation-free survival, monitored using a real time PCR assay for CMV DNA in plasma

    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.

    Measured: Up to day 100 post-transplant

  2. Percent cytotoxicity and ex vivo percent CD56+/CD107B+ cells

    Studied longitudinally in generalized linear models. Each of the 2 markers of NK function will be modeled separately.

    Measured: Day 120 post stem cell transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2010 (estimated)
  2. Study start11 Jan 2011
  3. Primary completion30 Dec 2013
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01199562
Sponsor's protocol ID
09038
Other IDs
NCI-2010-01932
Status last verified
Oct 2026
First submitted
8 Sep 2010
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes

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