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T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant

NCT00986557 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2013-08-26

No results posted yet for this study

Summary

RATIONALE: An infusion of cytomegalovirus-specific T lymphocytes may prevent or reduce cytomegalovirus infection during the first year after a donor stem cell transplant.

PURPOSE: This randomized phase II trial is studying T-lymphocyte infusion to see how well it works compared with standard therapy in treating patients at risk of cytomegalovirus infection after a donor stem cell transplant.

Conditions

Interventions

BIOLOGICAL

adoptive immunotherapy

BIOLOGICAL

alemtuzumab

BIOLOGICAL

in vitro-treated peripheral blood lymphocyte therapy

DRUG

foscarnet sodium

DRUG

ganciclovir

GENETIC

polymerase chain reaction

PROCEDURE

allogeneic hematopoietic stem cell transplantation

PROCEDURE

infection prophylaxis and management

PROCEDURE

peripheral blood stem cell transplantation

PROCEDURE

standard follow-up care

RADIATION

radiation therapy

Sponsors & Collaborators

  • University Hospital Birmingham

    lead OTHER

Principal Investigators

  • Frederick Chen, MD · University Hospital Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00986557 on ClinicalTrials.gov