Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058591
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2003-04-08
Brief Title:
Treating Severe Chronic Epstein-Barr Virus EBV Infection With EBV Specific Cytotoxic T Lymphocytes CTLs
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Autologous EBV Specific CTLs for Therapy of Severe Chronic EBV Infection
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCAEBV
Brief Summary:
Severe chronic active Epstein-Barr virus SCAEBV is a rare Epstein-Barr virus EBV or commonly known as mono or the kissing disease associated disorder This disorder may cause chronic tiredness and fevers and sometimes be complicated by life threatening problems such as multi-organ failure chronic ongoing pneumonia and lymphoproliferative diseases diseases involving the lymph nodes which could eventually show up as leukemia or a tumor The reasons for the bodys inability to control the EBV infection are still unknown and no effective treatment is currently available
This research study uses Epstein-Barr virus EBV specific cytotoxic T lymphocytes CTLs We want to see if we can grow special white blood cells called T cells that have been trained to kill EBV infected cells in the laboratory and see if these cells may help control the EBV infection when given back to the patient
The purpose of this study is to find the largest safe dose of EBV specific CTLs to learn what the side effects are and to see whether this therapy might help the body fight off the SCAEBV infection
This research study uses Epstein-Barr virus EBV specific cytotoxic T lymphocytes CTLs We want to see if we can grow special white blood cells called T cells that have been trained to kill EBV infected cells in the laboratory and see if these cells may help control the EBV infection when given back to the patient
The purpose of this study is to find the largest safe dose of EBV specific CTLs to learn what the side effects are and to see whether this therapy might help the body fight off the SCAEBV infection
Detailed Description:
Ten to sixty ml 2-12 teaspoons of blood will be collected from the patient which we use to grow the T cells These T cells are then stimulated with EBV infected cells which have been treated with radiation so that they cannot grow This stimulation trains the T cells to kill EBV infected cells We then test the T cells to make sure that they kill the EBV infected cells
Therapy can take place in one of the specifically designated outpatient clinics so hospital admission is not required First patients will be given doses of Tylenol for any achespains and Benadryl for any minor allergic reactions such as itchingrash Next the T cells will be injected into a vein over a 10 minute period Patients will be closely watched for any side effects
If a patient shows some response to the treatment they may receive up to three additional T cell injections at three month intervals Patients will need to be seen every other week in the clinic for six weeks after the injection Following that patients will either be seen in the clinic or contacted by one of the research staff working on this study once a month for one year
To learn more about the way the T cells are working and how long they last in the body an extra 40 mls8 teaspoonfuls of blood will be taken at these visits Additionally 3 mls 12 teaspoonful of blood will be taken prior to the infusion and monthly thereafter to conduct a CBC a test to look at the components of the blood
Therapy can take place in one of the specifically designated outpatient clinics so hospital admission is not required First patients will be given doses of Tylenol for any achespains and Benadryl for any minor allergic reactions such as itchingrash Next the T cells will be injected into a vein over a 10 minute period Patients will be closely watched for any side effects
If a patient shows some response to the treatment they may receive up to three additional T cell injections at three month intervals Patients will need to be seen every other week in the clinic for six weeks after the injection Following that patients will either be seen in the clinic or contacted by one of the research staff working on this study once a month for one year
To learn more about the way the T cells are working and how long they last in the body an extra 40 mls8 teaspoonfuls of blood will be taken at these visits Additionally 3 mls 12 teaspoonful of blood will be taken prior to the infusion and monthly thereafter to conduct a CBC a test to look at the components of the blood
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SCAEBV | None | None | None |