Patient case: 4-year-old female with leukemia; genetic feature: ABL1

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

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.

Eligibility: 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

Relevance to patient case: not relevant