Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058604
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2003-04-08
Brief Title:
Prevention and Treatment of Epstein-Barr Virus EBV Lymphoma Following a Solid Organ Transplant Using 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 Prophylaxis and Therapy of EBV Lymphoma Post Solid Organ Transplant
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:
EUCLID
Brief Summary:
Patients who may have been infected with EBV Epstein-Barr Virus before or after the time of their transplant have a higher risk of developing Lymphoproliferative Disease LPD or may already have a form of this disease
This research study uses Epstein Barr virus EBV specific cytotoxic T lymphocytes CTLs These cells have been trained to attack and kill cytotoxic EB virus infected cells
We make these cells from the patients blood by first growing an EBV infected B cell line by infecting the blood with an EBV virus called B-95 We then treat these EBV infected B cells with radiation so they cannot grow and use them to stimulate T cells This stimulation will train the T cells to kill EBV infected cells We will then test the T cells to make sure they kill the EBV infected cells
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 prevent or cure EBV related cancers in solid organ transplant patients
This research study uses Epstein Barr virus EBV specific cytotoxic T lymphocytes CTLs These cells have been trained to attack and kill cytotoxic EB virus infected cells
We make these cells from the patients blood by first growing an EBV infected B cell line by infecting the blood with an EBV virus called B-95 We then treat these EBV infected B cells with radiation so they cannot grow and use them to stimulate T cells This stimulation will train the T cells to kill EBV infected cells We will then test the T cells to make sure they kill the EBV infected cells
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 prevent or cure EBV related cancers in solid organ transplant patients
Detailed Description:
Participation in this study will be for one year Patients will receive this treatment either while in hospital or in the outpatient clinic Each patient will be entered into one of three different dosing schedules being evaluated Three to six patients will be evaluated on each dosing schedule Escalation will continue until unacceptable side effects are seen
First patients will be given Tylenol for any achespains and Benadryl for any minor allergic reactions such as itchingrash This is called premedication Next the T cells will be injected into the patients vein intravenously over approximately 10 minutes Patients will be closely watched during this time to make sure they do not experience any bad effects such as an allergic reaction If the patient does not respond to the T cells or if during follow-up examinations evidence of relapse is shown the patient may receive another higher dose of T cells approximately six weeks after their first injection Patients may decide NOT to continue to receive this therapy receive further injections however the follow-up period will still be for one year
Each patient will be seen every two weeks in the clinic or contacted every two weeks by the research nurse or other member of the research team for six weeks after the injections They will then be seen or contacted monthly for 3 months and then once every three months for one year and again if relapse occurs or is suspected
To learn more about the way the T cells are working and how long they last in the body 40 mls 8 teaspoonfuls of blood will be taken once before the injection of T-cells every two weeks for 6 weeks after the injection monthly for 3 months and then every 3 months for 1 year This amount of blood will be less for small patients We will also take another blood sample from the patient if relapse is suspected Each patient will need to have a physical examination by their physician to check on their progress
Additionally before the injection of T-cells once every two weeks after the injection for 6 weeks and once every month for 3 months and then once every 3 months for one year and again if relapse occurs or is suspected we will obtain a blood sample from the patient to evaluate for transplant rejection The amount of blood that we will take will be 3-5 mls 12 to 1 teaspoon If the patient has received a heart transplant they will also be asked to have other tests such as an ultrasound or tomography similar to an x-ray done to help with this evaluation
First patients will be given Tylenol for any achespains and Benadryl for any minor allergic reactions such as itchingrash This is called premedication Next the T cells will be injected into the patients vein intravenously over approximately 10 minutes Patients will be closely watched during this time to make sure they do not experience any bad effects such as an allergic reaction If the patient does not respond to the T cells or if during follow-up examinations evidence of relapse is shown the patient may receive another higher dose of T cells approximately six weeks after their first injection Patients may decide NOT to continue to receive this therapy receive further injections however the follow-up period will still be for one year
Each patient will be seen every two weeks in the clinic or contacted every two weeks by the research nurse or other member of the research team for six weeks after the injections They will then be seen or contacted monthly for 3 months and then once every three months for one year and again if relapse occurs or is suspected
To learn more about the way the T cells are working and how long they last in the body 40 mls 8 teaspoonfuls of blood will be taken once before the injection of T-cells every two weeks for 6 weeks after the injection monthly for 3 months and then every 3 months for 1 year This amount of blood will be less for small patients We will also take another blood sample from the patient if relapse is suspected Each patient will need to have a physical examination by their physician to check on their progress
Additionally before the injection of T-cells once every two weeks after the injection for 6 weeks and once every month for 3 months and then once every 3 months for one year and again if relapse occurs or is suspected we will obtain a blood sample from the patient to evaluate for transplant rejection The amount of blood that we will take will be 3-5 mls 12 to 1 teaspoon If the patient has received a heart transplant they will also be asked to have other tests such as an ultrasound or tomography similar to an x-ray done to help with this evaluation
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 |
|---|---|---|---|
| Euclid | None | None | None |