T Cell Therapy for Adenovirus in Immunocompromised Patients
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer, Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases, Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 9/16/2018 |
Start Date: | March 15, 2018 |
End Date: | September 2021 |
Contact: | David Marin, MD |
Email: | dmarin@mdanderson.org |
Phone: | 713-792-8750 |
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
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential
participant.
The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs)
can help to control adenovirus. Researchers also want to learn about the safety of giving
CTLs to patients with adenovirus.
CTLs are made from donated blood cells grown in the laboratory and are designed to kill
viruses that can cause infections.
This is an investigational study. The use of CTLs to treat adenovirus is not FDA approved. At
this time, CTLs are only being used to treat infections in research studies.
Up to 16 participants will be enrolled in this study. All will take part at MD Anderson.
participant.
The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs)
can help to control adenovirus. Researchers also want to learn about the safety of giving
CTLs to patients with adenovirus.
CTLs are made from donated blood cells grown in the laboratory and are designed to kill
viruses that can cause infections.
This is an investigational study. The use of CTLs to treat adenovirus is not FDA approved. At
this time, CTLs are only being used to treat infections in research studies.
Up to 16 participants will be enrolled in this study. All will take part at MD Anderson.
CTL Administration:
If you are found to be eligible to take part in this study, you will receive the CTLs by vein
(also called an infusion) over about 30 minutes. You will stay in the clinic for about 1 hour
after the CTL infusion so that you can be checked for any side effects you may have.
You will be given standard drugs to help decrease the risk of side effects. You may ask the
study staff for information about how the drugs are given and their risks.
If your doctor thinks it is needed, you may receive additional CTL infusions.
Length of Study:
You will take part in this study for 12 months after your final CTL infusion. Your
participation on this study will be over when you have completed the 12-month visit.
You will no longer be able to receive the CTL infusion(s) if the disease gets worse, if
intolerable side effects occur, if you need medical treatment not allowed in this study, or
if you are unable to follow study directions.
Study Visits:
Since you may have more than one CTL infusion, the study visit time points are based on the
time of your last CTL infusion.
Within 72 hours before each CTL infusion:
- You will have a physical exam.
- Blood (about 7 tablespoons) will be drawn for routine testing, to test for adenovirus,
and for genetic testing.
- Urine will be collected for routine tests.
- You will have a chest x-ray.
One (1) time each during Weeks 1-4, and then at 45 days and about 3, 6, and 12 months after
each CTL infusion:
- You will have a physical exam.
- You will have standard of care tests to check the status of graft versus host disease
(GVHD - a condition in which transplanted tissue attacks the body into which it is
transplanted).
- Blood (about 8 tablespoons) will be drawn for routine testing, to check for adenovirus,
and to test the effect of the CTLs on adenovirus and your immune system, and for genetic
testing.
- Urine will be collected for routine tests.
If you and the study doctor agree, you may be able to have the tests and procedures listed
above at a clinic near your home. Please talk to the study staff about this possible option.
If you are found to be eligible to take part in this study, you will receive the CTLs by vein
(also called an infusion) over about 30 minutes. You will stay in the clinic for about 1 hour
after the CTL infusion so that you can be checked for any side effects you may have.
You will be given standard drugs to help decrease the risk of side effects. You may ask the
study staff for information about how the drugs are given and their risks.
If your doctor thinks it is needed, you may receive additional CTL infusions.
Length of Study:
You will take part in this study for 12 months after your final CTL infusion. Your
participation on this study will be over when you have completed the 12-month visit.
You will no longer be able to receive the CTL infusion(s) if the disease gets worse, if
intolerable side effects occur, if you need medical treatment not allowed in this study, or
if you are unable to follow study directions.
Study Visits:
Since you may have more than one CTL infusion, the study visit time points are based on the
time of your last CTL infusion.
Within 72 hours before each CTL infusion:
- You will have a physical exam.
- Blood (about 7 tablespoons) will be drawn for routine testing, to test for adenovirus,
and for genetic testing.
- Urine will be collected for routine tests.
- You will have a chest x-ray.
One (1) time each during Weeks 1-4, and then at 45 days and about 3, 6, and 12 months after
each CTL infusion:
- You will have a physical exam.
- You will have standard of care tests to check the status of graft versus host disease
(GVHD - a condition in which transplanted tissue attacks the body into which it is
transplanted).
- Blood (about 8 tablespoons) will be drawn for routine testing, to check for adenovirus,
and to test the effect of the CTLs on adenovirus and your immune system, and for genetic
testing.
- Urine will be collected for routine tests.
If you and the study doctor agree, you may be able to have the tests and procedures listed
above at a clinic near your home. Please talk to the study staff about this possible option.
Inclusion Criteria:
1. Immunocompromised patients with any hematological malignancies.
2. Written informed consent and/or signed assent from patient, parent or guardian.
3. 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.
4. 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.
5. Patients with criteria of probable or definitive adenoviral diseases.
Exclusion Criteria:
1. Patients receiving prednisone >0.1 mg/kg/day or equivalent at time of enrollment, or
who have received ATG within 14 days or have received donor lymphocyte infusion (DLI)
or Campath within 28 days of enrollment.
2. 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.
3. Active acute GVHD Grade >/= 2.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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