Emergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections
NCT ID: NCT00769613
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2008-08-31
Brief Summary
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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.
Detailed Description
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Primary
* 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.
Secondary
* 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.
Conditions
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Keywords
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Study Design
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SUPPORTIVE_CARE
NONE
Interventions
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cytomegalovirus IE-1-specific cytotoxic T lymphocytes
cytomegalovirus pp65-specific cytotoxic T lymphocytes
therapeutic allogeneic lymphocytes
polymerase chain reaction
flow cytometry
immunological diagnostic method
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* 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
PATIENT CHARACTERISTICS:
* 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
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Must be on ≤ 1 mg/kg/day of prednisone or its equivalent at the time of study CTL infusion
2 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Milton S. Hershey Medical Center
OTHER
Principal Investigators
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Kenneth G. Lucas, MD
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Locations
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Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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Other Identifiers
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PSCI-PSHCI-08-051
Identifier Type: -
Identifier Source: secondary_id
CDR0000615167
Identifier Type: -
Identifier Source: org_study_id