Administration of Virus-Specific Cytotoxic T-Lymphocytes

Completed · Phase 1

Conditions studied: Adenovirus Infection

In brief

The main purpose of this study is to see if these T-lymphocytes are safe. To make these Ad-specific T lymphocytes the investigators will obtain blood from the stem cell donor and transfer Ad into another type of blood cell, called monocytes. These cells can then stimulate the T lymphocytes and train them to kill cells infected with Ad. The investigators will then grow these Ad-specific T lymphocytes by more stimulation with Ad-infected monocytes and a third type of blood cell called a B lymphoblast from the donor. After testing the T -lymphocytes, the investigators will inject them into patients after transplant who are at high risk of serious Ad virus infection. The investigators will make sure the injected cells are safe and see if they affect the growth and behavior of adenoviruses in the patient's own body.

Key facts

Study ID

NCT00590083

Run by

Baylor College of Medicine

People needed

14

Starts

2003-07-01

Expected to finish

2011-01-01

Last updated by the study team

2014-02-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recipients of allogeneic (i.e. HLA matched or mismatched related or unrelated) donor stem cell transplants at risk for Adenoviral disease
• No evidence of GVHD > Grade II at time of enrollment
• Life expectancy > 30 days
• No severe intercurrent infections
• Lansky/Karnofsky scores >60
• Absence of severe renal disease (Creatinine > x 3 normal for age)
• Absence of severe hepatic disease (direct bilirubin > 3 mg/dl or SGOT > 500)
• Patient must be at least 30 days post transplant to be eligible to receive CTL
• Not receiving Cidofovir
• Patient has not received other viral specific CTL prophylactically within 4 weeks of receiving Adv-CTL
• Patient/guardian able to give informed consent

You may not qualify if…

• Patients with GVHD Grades III-IV
• Patients with hepatic or renal disease as specific above
• Patient has received other viral specific CTL (e.g. EBV-specific CTL or CMV-specific CTL) within 4 weeks of receiving Adv-CTL
• Patients with Adenoviral disease prior to day +30 post transplant Adenoviral diseases defined as the presence of more than two sites positive for adenovirus by culture
• Patients with less than 50% donor chimerism in either peripheral blood or bone marrow or patients with relapse of original disease

Where it is running

• National Institute of Health (NIH) — Washington D.C., District of Columbia, United States
• Texas Children's Hospital — Houston, Texas, United States
• The Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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