Anti-viral Treatment Following Bone Marrow Transplant
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/30/2018 |
| Start Date: | February 5, 2014 |
| End Date: | December 2020 |
| Contact: | Jamie Wilhelm, BS |
| Email: | Jamie.Wilhelm@cchmc.org |
| Phone: | (513) 803-1102 |
Donor-Derived Anti-viral CTLs for Treatment of Viral Infections After Allogeneic Stem Cell Transplant
In this research study, we want to learn more about the use of donor-derived cytotoxic
T-cells (CTLs) to treat viral infections that occur after allogeneic stem cell transplant. A
cytotoxic T cell is a T lymphocyte (a type of white blood cell) that kills cells that are
infected (particularly with viruses). Allogeneic means the stem cells come from another
person. These CTLs are cells specially designed to fight the virus infections that can happen
after a bone marrow transplant.
We are asking people who have undergone or will undergo an allogeneic stem cell transplant to
enroll in this research study, because viral infections are a common problem after allogeneic
stem cell transplant and can cause significant complications including death.
Stem cell transplant reduces a person's ability to fight infections. There is an increased
risk of getting new viral infections or reactivation of viral infections that the patient has
had in the past, such as cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus (ADV),
and BK virus (BKV). There are anti-viral medicines available to treat CMV, EBV, ADV, and BK
infections, though not all patients will respond to the standard treatments. Moreover,
treatment of viral infections is expensive and time consuming, with families often
administering prolonged treatments with intravenous anti-viral medications, or patients
requiring prolonged admissions to the hospital. The medicines can also have side effects like
damage to the kidneys or reduction in the blood counts, so in this study we are trying to
find an easier way to treat these infections.
T-cells (CTLs) to treat viral infections that occur after allogeneic stem cell transplant. A
cytotoxic T cell is a T lymphocyte (a type of white blood cell) that kills cells that are
infected (particularly with viruses). Allogeneic means the stem cells come from another
person. These CTLs are cells specially designed to fight the virus infections that can happen
after a bone marrow transplant.
We are asking people who have undergone or will undergo an allogeneic stem cell transplant to
enroll in this research study, because viral infections are a common problem after allogeneic
stem cell transplant and can cause significant complications including death.
Stem cell transplant reduces a person's ability to fight infections. There is an increased
risk of getting new viral infections or reactivation of viral infections that the patient has
had in the past, such as cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus (ADV),
and BK virus (BKV). There are anti-viral medicines available to treat CMV, EBV, ADV, and BK
infections, though not all patients will respond to the standard treatments. Moreover,
treatment of viral infections is expensive and time consuming, with families often
administering prolonged treatments with intravenous anti-viral medications, or patients
requiring prolonged admissions to the hospital. The medicines can also have side effects like
damage to the kidneys or reduction in the blood counts, so in this study we are trying to
find an easier way to treat these infections.
The stem cell matched donor will be asked to give us a blood donation for the CTLs
generation. In the laboratory, we will treat this blood sample to select out the cells that
will help fight viruses. The cells will be grown with peptides (protein fragments that
represent parts of the virus that will encourage the donor immune cells to grow). We will
then grow the cells in the laboratory so that we will have a stock of virus fighting cells
for the patient to use in the future. We will freeze the cells and store them in a freezer in
the laboratory.
If the patient has signs of virus in their blood after the transplant we will give the cells
to help fight the infection. If there are signs that the cells are helping fight the
infection, we may give more cells. The patient may get the cells up to 5 times, with one
month between each treatment. If the patient does not show signs of a virus, the cells will
stay in the freezer.
Following CTL infusion, (s)he will be monitored with physical exams daily while inpatient and
weekly while outpatient as well as blood tests weekly until 30 days after the last infusion
of cells. The patient will have 3 teaspoons (15 mL) of blood drawn before each cell infusion
and then once a week after each infusion for 4 weeks and then once a month if possible for 1
year after the last infusion, all to monitor for the viral response.
generation. In the laboratory, we will treat this blood sample to select out the cells that
will help fight viruses. The cells will be grown with peptides (protein fragments that
represent parts of the virus that will encourage the donor immune cells to grow). We will
then grow the cells in the laboratory so that we will have a stock of virus fighting cells
for the patient to use in the future. We will freeze the cells and store them in a freezer in
the laboratory.
If the patient has signs of virus in their blood after the transplant we will give the cells
to help fight the infection. If there are signs that the cells are helping fight the
infection, we may give more cells. The patient may get the cells up to 5 times, with one
month between each treatment. If the patient does not show signs of a virus, the cells will
stay in the freezer.
Following CTL infusion, (s)he will be monitored with physical exams daily while inpatient and
weekly while outpatient as well as blood tests weekly until 30 days after the last infusion
of cells. The patient will have 3 teaspoons (15 mL) of blood drawn before each cell infusion
and then once a week after each infusion for 4 weeks and then once a month if possible for 1
year after the last infusion, all to monitor for the viral response.
Inclusion Criteria:
- Recipient must be at least 28 days after stem cell infusion
- Clinical status must allow tapering of steroids to 0.5mg/kg prednisone or other
steroid equivalent
- Recipient must have achieved engraftment with ANC ≥ 500
Exclusion Criteria:
- Active acute GVHD grades II-IV
- Uncontrolled bacterial or fungal infection
- Uncontrolled relapse of malignancy
- Infusion of ATG or alemtuzumab within 2 weeks of CTL infusion
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Principal Investigator: Michael Grimley, MD
Phone: 513-803-1102
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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