Cytotoxic T-Lymphocytes for the Prophylaxis of Cytomegalovirus After Allogeneic Stem Cell Transplant

Completed · Phase 1

Conditions studied: Cytomegalovirus Infections

In brief

Patients have a type of blood cell cancer, other blood disease or a genetic disease for which they will receive a stem cell transplant. The donor of the stem cells will be either a brother or sister or another relative or a closely matched unrelated donor. We are asking patients to participate in this study which tests if blood cells from the donor that have been grown in a special way, can prevent the patients from getting an infection with a virus called Cytomegalovirus or CMV. CMV is a virus that can cause serious infections in patients with suppressed immune systems. It usually affects the lungs and can cause a very serious pneumonia, but it can also affect the intestinal tract, the liver and the eyes. Approximately 2/3 of normal people harbor this virus in their body. In healthy people CMV rarely causes any problems because the immune system can keep it under control. If the patient and/or their donor is positive for CMV, they are at risk of developing CMV disease while the patients immune system is weak post transplant. Usually, this risk is highest during the first 3-4 months after the transplant. CMV disease can be prevented during this time in most people by using drugs that can kill the virus such as Ganciclovir, Foscarnet, or Cidofovir . However, these medications have many side effects and have to be given daily by vein for approximately 4-5 months after transplant. One of the side effects is that it takes the new immune system much longer to develop an effective defense against the virus. Therefore, once the medicines are stopped, the patients still have a chance to develop CMV disease. We want to see if we can use a kind of white blood cell called T cells that we have grown from the stem cell donor instead of the regular treatment with Ganciclovir or Foscarnet to prevent CMV from "flaring up". These cells have been trained to attack CMV virus infected cells. We will grow these T cells from blood taken from the donor before the patients transplant. These cells are called CMV-specific cytotoxic T-lymphocytes or CMV CTL, and they will be given to the patient around 30 days after their transplant. We have used this sort of therapy to treat a different virus which can cause problems after transplant called Epstein Barr Virus (EBV). Doctors at other places have used similar T cells to treat or prevent CMV infections after transplant and have not seen any significant problems. These CMV specific cytotoxic T cells are an investigational product not approved by the Food and Drug Administration.

Key facts

Study ID: NCT00078533
Run by: Baylor College of Medicine
People needed: 26
Starts: 2004-04-01
Expected to finish: 2011-06-01
Last updated by the study team: 2014-10-08

Who can join

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

You may qualify if…

Recipients of allogeneic donor stem cell transplants at risk for CMV reactivation with a CMV seropositive stem cell donor and at least 30 days post transplant.
Recipients can have early evidence of CMV reactivation with greater than 2 leukocytes but less than 10 leukocytes positive for the CMV Ag per 100,000 cells.
No evidence of graft-versus-host disease (GVHD) > Grade II at time of enrollment.
Life expectancy > 30 days
No severe intercurrent infections
Lansky/Karnofsky scores greater than or equal to 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)
Not receiving Ganciclovir, Foscarnet, or Cidofovir or other antiviral therapy for CMV reactivation
Patient/guardian able to give informed consent

You may not qualify if…

Patients with CMV negative stem cell donors
Patients with GVHD Grades III-IV
Patients receiving antiviral therapy for CMV reactivation or other viral infections such as adenovirus or herpes viruses
Patients with significant CMV reactivation. Significant CMV reactivation is defined as one CMV Antigenemia reading with >10 leukocytes positive for the CMV Ag per 100,000 cells
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

Houston Methodist Hospital — Houston, Texas, United States
Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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