Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058773
Status:
TERMINATED
Last Update Posted:
2012-11-06
First Post:
2003-04-11
Brief Title:
Giving Gene Marked EBV Specific T-Cells to Patients Receiving a BMT for Relapsed EBV-Positive Hodgkin Disease
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Administration of Autologous Neomycin Resistant Gene Marked EBV Specific Cytotoxic T-Lymphocytes as Therapy for Patients Receiving Autologous Bone Marrow Transplant for Relapsed EBV-Positive Lymphoma
Status:
TERMINATED
Status Verified Date:
2012-11
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:
ANGELA
Brief Summary:
Subjects 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 we know for relapsed Lymphoma We are asking subjects to volunteer to be in a research study using Epstein Barr virus EBV 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 disease or non-Hodgkin Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus EBV before or at the time of their diagnosis of 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 We want to see if we can grow special white blood cells called T cells that have been trained to kill EBV infected cells and give them back to subjects
Some patients with Hodgkin disease or non-Hodgkin Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus EBV before or at the time of their diagnosis of 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 We want to see if we can grow special white blood cells called T cells that have been trained to kill EBV infected cells and give them back to subjects
Detailed Description:
We will take 60-70 ml 12 teaspoonfuls of blood from the subject We will first make a B cell line called a lymphoblastoid cell line or LCL by infecting the subjects blood with a laboratory strain of EBV called B95 We will then use 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 We will then test the T cells to make sure that they kill the EBV infected cells and not your normal cells and freeze them
The cells will be thawed and injected into subjects over 10 minutes after pretreatment with Tylenol and Benadryl A total of two doses will be given two weeks apart All of the treatments will be given at Texas Childrens Hospital or The Methodist Hospital
We will follow subjects in the clinic after the injections At each visit about 10ml 2 teaspoonfuls of blood will be taken every other week for 6 weeks after the injection and then every 3 months for 1 year to monitor the subjects blood chemistry and hematology
To learn more about the way the T cells are working in the subjects body an extra 40mls 8 teaspoons of blood will be taken pre-infusion 3-4 days post infusion optional and at 1 2 4 and 6 weeks post-infusion and then at 3 6 9 and 12 months The blood may be drawn from the subjects central line at the time of their regular blood tests
The cells will be thawed and injected into subjects over 10 minutes after pretreatment with Tylenol and Benadryl A total of two doses will be given two weeks apart All of the treatments will be given at Texas Childrens Hospital or The Methodist Hospital
We will follow subjects in the clinic after the injections At each visit about 10ml 2 teaspoonfuls of blood will be taken every other week for 6 weeks after the injection and then every 3 months for 1 year to monitor the subjects blood chemistry and hematology
To learn more about the way the T cells are working in the subjects body an extra 40mls 8 teaspoons of blood will be taken pre-infusion 3-4 days post infusion optional and at 1 2 4 and 6 weeks post-infusion and then at 3 6 9 and 12 months The blood may be drawn from the subjects central line at the time of their regular blood tests
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 |
|---|---|---|---|
| ANGELA | None | None | None |