Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes.
- Who it may be relevant to
- Registry conditions: Hematopoietic and Lymphoid Cell Neoplasm, Immunocompromised. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Administration of Off-the-Shelf, Expanded, Most Closely HLA Matched, Third Party Adenovirus Specific T Cells for Therapy of Adenovirus Related Disease in Immunocompromised Patients
Overview
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.
Detailed description
PRIMARY OBJECTIVES:
I. To assess the feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched adenovirus specific T cell lines generated by ex vivo expansion as therapy of asymptomatic adenovirus viremia or adenovirus-related disease in immunocompromised hosts.
SECONDARY OBJECTIVES:
I. To obtain preliminary data about the efficacy of administering most closely HLA-matched adenovirus specific T cell lines generated by ex vivo expansion as therapy of adenovirus viremia or adenovirus-related disease.
II. To assess the persistence of the administered cells in the patients.
OUTLINE:
Within two weeks of enrollment, patients receive allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs) intravenously (IV) over 30 minutes. Patients may receive additional allogeneic adenovirus-specific CTL infusions at the discretion of the investigator in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 12 months.
Interventions
- Biological Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes
Given IV
Primary outcome measures
- Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0 [Time frame: Up to 1 year]
- Assessment of response to allogeneic adenovirus-specific cytotoxic T lymphocytes (CTLs) [Time frame: Up to 1 year]
Secondary outcome measures (5)
- Overall survival (OS) [Time frame: From the start of study treatment up to 1 year]
- Relapse-free survival (RFS) [Time frame: From the start of study treatment up to 1 year]
- Cumulative incidence of adenovirus reactivation after therapy [Time frame: Up to 1 year]
- Cumulative incidence of graft versus host disease (GVHD) [Time frame: Up to 1 year]
- Reconstitution of anti-adenovirus immunity [Time frame: Up to 1 year]
Eligibility criteria
Inclusion criteria
- 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.
- Patients age 1 year or older with asymptomatic adenovirus viremia defined as no symptoms of adenovirus disease and EITHER two positive and quantifiable qPCR tests taken one week apart or one single measurement with >/= 1000 copies.
- Patients age 1 year or older with criteria of probable or definitive adenoviral diseases as defined in Appendix A.
- Willingness to comply with the study protocol requirements.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT03425526 · 2017-0350 · NCI-2018-00929 · 2017-0350