Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorM.D. Anderson Cancer Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Allogeneic BK-specific Cytotoxic T-lymphocytes

    Biological/Vaccine

    Given IV

  • Laboratory Biomarker Analysis

    Other intervention

    Correlative studies

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Treatment (BK-specific cytotoxic T lymphocytes)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 56 days
2

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.

Time frame
Within 28 days of the last dose of cytotoxic T lymphocytes (CTLs)
3

Incidence of adverse events

Will be continuously monitored.

Time frame
Up to day 100

Secondary outcomes

1

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.

Time frame
Up to 12 months
2

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.

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator