Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058617
Status:
COMPLETED
Last Update Posted:
2017-02-15
First Post:
2003-04-08
Brief Title:
Epstein Barr Virus EBV Specific Cytotoxic T-Cells Relapsed Lymphoma ANGEL
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Administration of Neomycin Resistance Gene Marked EBV Specific Cytotoxic T-Lymphocytes to Patients With Relapsed EBV-Positive Lymphoma
Status:
COMPLETED
Status Verified Date:
2017-02
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:
None
Brief Summary:
Patients have a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma which has come back or not gone away after treatment including the best treatment known for relapsed Lymphoma
Patients are being asked to volunteer to be in a research study using Epstein Barr virus specific cytotoxic T lymphocytes a new experimental therapy This therapy has never been used in patients with Hodgkin disease or this type of non-Hodgkin Lymphoma but it has been used successfully in children with other types of blood cancer caused by EBV after bone marrow transplantation Some patients with Hodgkin or non-Hodgkin Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus before or at the time of their diagnosis of the Lymphoma EBV is often found in the cancer cells suggesting that it may play a role in causing Lymphoma The cancer cells infected by EBV are very clever because they are able to hide from the bodys immune system and escape destruction Investigators want to see if its possible to grow special white blood cells called T cells that have been trained to kill EBV infected cells
Purpose The purpose of this study is to find the largest safe dose of EBV specific cytotoxic T cells to learn what the side effects are and to see whether this therapy might help patients with Hodgkin disease and non-Hodgkin Lymphoma
Patients are being asked to volunteer to be in a research study using Epstein Barr virus specific cytotoxic T lymphocytes a new experimental therapy This therapy has never been used in patients with Hodgkin disease or this type of non-Hodgkin Lymphoma but it has been used successfully in children with other types of blood cancer caused by EBV after bone marrow transplantation Some patients with Hodgkin or non-Hodgkin Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus before or at the time of their diagnosis of the Lymphoma EBV is often found in the cancer cells suggesting that it may play a role in causing Lymphoma The cancer cells infected by EBV are very clever because they are able to hide from the bodys immune system and escape destruction Investigators want to see if its possible to grow special white blood cells called T cells that have been trained to kill EBV infected cells
Purpose The purpose of this study is to find the largest safe dose of EBV specific cytotoxic T cells to learn what the side effects are and to see whether this therapy might help patients with Hodgkin disease and non-Hodgkin Lymphoma
Detailed Description:
The investigators will take 60-70 ml 12 teaspoonfuls of blood from the patient to make a B cell line called a lymphoblastoid cell line or LCL by infecting the blood with a laboratory strain of EBV called B95-8 The investigators will then use this EBV infected cell line which have been treated with radiation so that they cannot grow as stimulator cells and mix it with more blood This stimulation will train the T cells to kill EBV infected cells and result in the growth of an EBV specific T cell line The investigators will then test the T cells to make sure that they kill the EBV infected cells and not normal cells and freeze them
Patients 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 irreversible or life threatening side effects considered to be related to the T cells are seen
The cells will then be thawed and injected into the patients vein over 10 minutes after pretreatment with Tylenol and Benadryl Tylenol and Benadryl are given to prevent a possible allergic reaction to the T cell administration Initially two doses of T cells will be given two weeks apart If after the second infusion there is a reduction in the size of the patients lymphoma on CT or MRI scan as assessed by a radiologist the patient can receive up to six additional doses of the T cells All of the treatments will be given at Texas Childrens Hospital or the Methodist Hospital
Patients will be followed in the clinic after the injections To learn more about the way the T cells are working and how long they last in the body an extra 40 mls 8 teaspoonfuls of blood will be taken before each infusion and then 24 hours after each infusion 3-4 days after each infusion and at 1 2 4 and 6 weeks post infusion and then at 3 6 9 and 12 months post infusion The blood may be drawn from the central line at the time of regular blood tests This blood will be used to test for the frequency and activity of EBV specific T cells A total of at least 122 teaspoons approximately 40 tablespoons of blood will be collected during participation in this study
If the patient decide to withdraw at any time during the study both samples and data collected during participation will be maintained
Patients 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 irreversible or life threatening side effects considered to be related to the T cells are seen
The cells will then be thawed and injected into the patients vein over 10 minutes after pretreatment with Tylenol and Benadryl Tylenol and Benadryl are given to prevent a possible allergic reaction to the T cell administration Initially two doses of T cells will be given two weeks apart If after the second infusion there is a reduction in the size of the patients lymphoma on CT or MRI scan as assessed by a radiologist the patient can receive up to six additional doses of the T cells All of the treatments will be given at Texas Childrens Hospital or the Methodist Hospital
Patients will be followed in the clinic after the injections To learn more about the way the T cells are working and how long they last in the body an extra 40 mls 8 teaspoonfuls of blood will be taken before each infusion and then 24 hours after each infusion 3-4 days after each infusion and at 1 2 4 and 6 weeks post infusion and then at 3 6 9 and 12 months post infusion The blood may be drawn from the central line at the time of regular blood tests This blood will be used to test for the frequency and activity of EBV specific T cells A total of at least 122 teaspoons approximately 40 tablespoons of blood will be collected during participation in this study
If the patient decide to withdraw at any time during the study both samples and data collected during participation will be maintained
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| ANGEL | OTHER | Baylor College of Medicine | None |