About this trial
This phase II trial studies how well donor cytotoxic T lymphocytes work in treating patients with malignancies with BK and/or JC virus. Cytotoxic T lymphocytes are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections in transplant patients and may be an effective treatment in patients with malignancies with BK and/or JC virus.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 2 years.
English and non-English speaking patients are eligible.
Immunocompromised patients including but not limited to those with any type of malignancy, HIV/AIDS, or history of solid organ transplant
Non-immunocompromised patients with PML/JC virus encephalitis
Disqualifiers
Patients receiving > 6 mg / day of prednisone or equivalent at time of
Patients who have received ATG within 14 days of enrollment
Patients who have received donor lymphocyte infusion (DLI) within 28 days of enrollment.
Patients who have received alemtuzumab within 28 days of enrollment.
Trial design
Single group
Treatments tested in this trial
Allogeneic BK-specific Cytotoxic T-lymphocytes
Biological/VaccineGiven IV
Laboratory Biomarker Analysis
Other interventionCorrelative studies
Treatment groups
Trial outcomes
Primary outcomes
Response, defined as response (R) = (best response [R1] or second best response [R2])
The method of Thall et al will be used to monitor the probabilities of response.
Incidence of acute graft-versus-host disease (GVHD)
The method of Thall et al will be used to monitor the probabilities of grade 3 or 4 GVHD.
Incidence of adverse events
Will be continuously monitored.
Secondary outcomes
Overall survival
Each outcome will be evaluated by tabulation and by fitting a Bayesian statistical regression model for binary outcomes as a function of covar. Unadjusted event time distributions will be estimated using the Kaplan-Meier method.
Glomerular filtration rate
Each outcome will be evaluated by tabulation and by fitting a Bayesian statistical regression model for binary outcomes as a function of covar. Unadjusted event time distributions will be estimated using the Kaplan-Meier method.
Sponsors and contacts
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M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator