Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorM.D. Anderson Cancer Center
About this trial
This phase I trial studies the side effects of allogeneic adenovirus-specific cytotoxic T lymphocytes (donor T cell therapy) and to see how well they work in treating patients with a weakened immune system (immunocompromised) and adenovirus-related disease. Allogeneic adenovirus-specific cytotoxic T lymphocytes are made from donated blood cells grown in the laboratory and are designed to kill viruses that can cause infections in immunocompromised patients with adenovirus-related disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Immunocompromised patients.
English and non-English speaking patients.
Written informed consent and/or signed assent from patient, parent or guardian.
Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
Disqualifiers
Patients receiving prednisone > 0.1 mg/kg/day or equivalent at time of enrollment, or who have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment.
Patients with other uncontrolled infections: For bacterial infections, patients must be receiving therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
Active acute graft versus host disease (GVHD) grade >= 2.
Trial design
Design model
Single group
Treatments tested in this trial
Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes
Biological/VaccineGiven IV
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Treatment (allogeneic adenovirus-specific CTLs)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0
Safety and tolerability will be assessed by laboratory assessments, adverse events, and serious adverse events. Adverse events will be graded by the CTCAE version 4.0. Categorical measures will be summarized using frequencies and percentages while continuous variables will be summarized using means, standard deviations, medians, minimums, and maximums.
Time frame
Up to 1 year2
Assessment of response to allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs)
The proportion of patients experiencing response will be computed with associated 95% confidence interval (CI). The 95% exact CI for the feasibility criterion of 50% will extend from 25% to 75% for 16 patients.
Time frame
Up to 1 yearSecondary outcomes
1
Overall survival (OS)
OS will be defined from treatment start date to date of death. Patients who are still alive at end of study will be censored. OS will be estimated using the Kaplan-Meier method.
Time frame
From the start of study treatment up to 1 year2
Relapse-free survival (RFS)
RFS (original malignancy) will be defined from treatment start date to the date of documented disease recurrence or death. Patients who are still alive without disease progression at end of study will be censored. RFS will be estimated using the Kaplan-Meier method.
Time frame
From the start of study treatment up to 1 year3
Cumulative incidence of adenovirus reactivation after therapy
Cumulative incidence of adenovirus reactivation after therapy will be assessed using the competing risks method. The competing risks will include relapse and death and patients who are still alive without disease progression at end of study will be censored.
Time frame
Up to 1 year4
Cumulative incidence of graft versus host disease (GVHD)
Cumulative incidence of grade 2-4 GVHD, grade 3-4 GVHD, and chronic GVHD will be assessed using the competing risks method. The competing risks will include relapse and death and patients who are still alive without disease progression at end of study will be censored.
Time frame
Up to 1 yearSponsors 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
Source ClinicalTrials.gov