Last updated on August 2018

Third-Party Cytotoxic T-Lymphocytes (CTLs) for Cytomegalovirus (CMV) Infection

Brief description of study

If you are reading and signing this form on behalf of a potential participant, please note: 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 about the safety of giving cytotoxic T lymphocytes (CTLs) to patients who have cytomegalovirus (CMV) infection. Researchers also want to learn if these cells can help to control CMV.

This is an investigational study. The use of CTLs to treat infection is not FDA approved or commercially available. CTLs are currently being used for research purposes only.

Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.

Detailed Study Description

The CTLs:

CTLs are made at MD Anderson from healthy donor blood cells. The healthy donors were donating blood stem cells for stem cell transplant patients. The cells are from a donor who at least partially matches you and your donor. All donors have been screened in the same way as routine blood donors.

CTL Administration:

If you are found to be eligible to take part in this study, you will receive the CTLs by vein. 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.

You will remain in the clinic for at least 1 hour after the CTL infusion so that you can be checked on. Your oxygen level will be measured by pulse oximetry. For this test, a clothespin-shaped clip will be placed on your finger for at least 30 minutes.

If the infection partially responds, gets worse, or stays the same, or does not respond to the CTLs, you may receive another infusion of CTLs at least 2 weeks after your first infusion.

Study Visits:

Within 72 hours before the infusion:

  • You will have a physical exam.
  • Blood (about 2 tablespoons) will be drawn for routine tests.

On the day of the infusion, and then about 1 week, 2 weeks, 3 months, and 6 months after the infusion, blood (about 1 tablespoon) will be drawn to check the status of the virus, to check your immune system, and to check the status of the CMV-specific CTLs. If blood is being drawn for other reasons at these timepoints, then extra blood will be drawn and used for these tests. In that case, you will not have to have another needlestick on those days.

At about 1, 2, 3, and 4 weeks and about 3, 6, and 12 months after the infusion:

  • You will have a physical exam. During the physical exam, you will be checked for possible reactions to the study drug, including graft versus host disease (GVHD -- when transplanted donor tissue attacks the tissues of the recipient's body) at Months 3, 6, and 12 after the infusion.
  • Blood (about 2 tablespoons) will be drawn for routine tests. If the doctor thinks it is needed, part of this blood will be used to check the status of the virus. During the Week 4 visit, part of this blood sample will be used to check for HAMA immune system reactions.

At Months 2, 4, 5, and 7-11 after the infusion, blood (about 2 tablespoons) will be drawn to check the status of the virus if the doctor thinks it is needed.

At Month 9 after the infusion, you will be checked for GVHD.

If you have 2 CTL infusions, these study visits will restart after the last infusion.

Starting at Week 1, you can have blood drawn for the study at a local lab or clinic that is closer to your home. The results will be sent to the study doctor at MD Anderson.

Length of Study:

Your participation on this study will end after your last follow-up visit 12 months after your last infusion. You will be taken off study early if you are unable to receive the first CTL infusion, if the doctor thinks it is in your best interest, if the disease gets worse or comes back, if intolerable side effects occur, or if you are unable to follow study directions.

Clinical Study Identifier: NCT02210078

Contact Investigators or Research Sites near you

Start Over

Betul Oran, MD

University of Texas MD Anderson Cancer Center
Houston, TX United States
  Connect »