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

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ClinicalTrials.gov Identifier: NCT00769613
Recruitment Status : Unknown
Verified August 2010 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : October 9, 2008
Last Update Posted : December 18, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE October 8, 2008
First Posted Date  ICMJE October 9, 2008
Last Update Posted Date December 18, 2013
Study Start Date  ICMJE August 2008
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2008)
  • Safety
  • Toxicity
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00769613 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2008)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Emergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description

OBJECTIVES:

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.

Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE
  • 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
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 8, 2008)
20
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00769613
Other Study ID Numbers  ICMJE CDR0000615167
PSCI-PSHCI-08-051
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Kenneth G. Lucas, MD Milton S. Hershey Medical Center
PRS Account National Cancer Institute (NCI)
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP