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Emergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: October 8, 2008
Last updated: December 17, 2013
Last verified: August 2010

RATIONALE: White blood cells that have been treated in the laboratory may kill cells that are infected with cytomegalovirus.

PURPOSE: This phase I trial is studying how well cytotoxic T cells work in treating patients who have undergone donor stem cell transplant and have cytomegalovirus infections.

Condition Intervention Phase
Biological: cytomegalovirus IE-1-specific cytotoxic T lymphocytes
Biological: cytomegalovirus pp65-specific cytotoxic T lymphocytes
Biological: therapeutic allogeneic lymphocytes
Genetic: polymerase chain reaction
Other: flow cytometry
Other: immunological diagnostic method
Other: laboratory biomarker analysis
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Emergency Access to C.V. pp65 / IE-1 Specific Cytotoxic T Lymphocytes for Recipients of Allogeneic Stem Cell Transplants With Persistant or Therapy Refractory Infections

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety
  • Toxicity

Secondary Outcome Measures:
  • Time to development of cytomegalovirus (CMV)-specific immune reconstitution
  • CMV DNA levels
  • Time during post-infusion follow-up at which the dominant CMV pp65- and IE-1 epitopes for the donor is recognized by the cytotoxic T-cell lymphocytes (CTL)
  • Feasibility of CMV pp65- and IE-1 CTL culture after CMV vaccination of seronegative donors

Estimated Enrollment: 20
Study Start Date: August 2008
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Detailed Description:



  • To provide access to cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T lymphocytes (CTL) in patients with persistent CMV infections after allogeneic stem cell transplantation.


  • To characterize CMV pp65- and IE-1-specific immune responses in terms of cytotoxicity and cytokine production pre-infusion and then periodically thereafter.
  • To characterize the levels of CMV DNA in recipients of CMV pp65- and IE-1-specific CTL and observe whether the CTL infusion has any impact on level of virus.
  • To determine the feasibility of CMV CTL culture from CMV-seronegative donors who have received a CMV vaccine.

OUTLINE: This is a multicenter study.

Patients receive allogeneic cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T-cell lymphocytes infusion over 5 minutes on day 1. Patients may receive up to 2 more doses at least 2 weeks after previous dose.

Blood samples are collected and analyzed by quantitative CMV PCR, chromium-release assays for CMV pp65- and IE-1-specific cytotoxicity, and immunophenotype for CD3, CD4, CD8, CD56, CD19, and CD45RA/RO. Intracellular cytofluorometry is used to assess IL-2, IL-4, IL-10, and IFN-γ production by CD4 and CD8 CMV-specific effector cells.

After completion of study therapy, patients are followed periodically for up to 1 year.


Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Recipient of an allogeneic stem cell transplantation
  • Cytomegalovirus (CMV)-seropositive and meeting 1 of the following criteria:

    • Patient has a history of CMV antigenemia for ≥ 2 weeks
    • CMV DNA levels ≥ 600 copies/mcg of DNA despite antiviral therapy targeting CMV (e.g., ganciclovir or foscarnet)
  • No ongoing graft-vs-host disease
  • Has donor available for peripheral blood mononuclear cell collection (for cytotoxic T lymphocytes production), meeting either of the following criteria:

    • CMV-seropositive donor (≥ 2 years of age)
    • CMV-seronegative related donor (≥ 18 years of age) who consents to receive the CMV vaccine


  • ECOG performance status (PS) 0-3 OR Lansky PS 50-100% (for patients < 16 years of age)
  • Bilirubin < 2.0 mg/dL
  • AST and ALT < 2.5 times normal
  • Creatinine clearance ≥ 30 mL/min
  • Pulse oximetry ≥ 94% on no more than 40% oxygen by face mask
  • Not moribund
  • No patients expected to survive ≤ 1 month after the T-cell infusion due to cardiac, pulmonary, renal, hepatic, or neurologic dysfunction


  • See Disease Characteristics
  • Must be on ≤ 1 mg/kg/day of prednisone or its equivalent at the time of study CTL infusion
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Please refer to this study by its identifier: NCT00769613

United States, Pennsylvania
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Cancer Institute (NCI)
Principal Investigator: Kenneth G. Lucas, MD Milton S. Hershey Medical Center
  More Information Identifier: NCT00769613     History of Changes
Other Study ID Numbers: CDR0000615167
Study First Received: October 8, 2008
Last Updated: December 17, 2013

Keywords provided by National Cancer Institute (NCI):
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult Hodgkin lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage III marginal zone lymphoma
stage III small lymphocytic lymphoma
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Hodgkin lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma

Additional relevant MeSH terms:
Cytomegalovirus Infections
Disease Attributes
Pathologic Processes
Herpesviridae Infections
DNA Virus Infections
Virus Diseases processed this record on April 26, 2017