Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058812
Status:
COMPLETED
Last Update Posted:
2015-01-29
First Post:
2003-04-11
Brief Title:
Giving Epstein-Barr Virus EBV Specific Killer T Lymphocytes to Patients Who Have Had Donor Marrow Grafts
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Administration of EBV Specific Cytotoxic T Lymphocytes to Recipients of Mismatched-Related or Phenotypically Similar Unrelated Donor Marrow Grafts
Status:
COMPLETED
Status Verified Date:
2015-01
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:
ETNA
Brief Summary:
Patients have a type of blood cell cancer or other blood problem that is very hard to cure with standard treatments and she will receive a bone marrow transplant If the patient does not have a brother or sister whose marrow is a perfect match this bone marrow will come from a donor whose marrow is the best match available This person may be a close relative or an unrelated person whose bone marrow best matches the patients and who agrees to donate marrow
In normal people the Epstein-Barr EB virus infection causes a flu like illness and usually gets better when the immune system controls the infection The virus however remains hidden in the body for life After a transplant while the new immune system is growing back the EB virus can come out and infect cells and cause them to grow in an uncontrolled manner Patients can develop fevers swollen lymph nodes and damage to other organs such as kidneys and lungs This infection acts like a cancer because the cells infected with EB virus grow very quickly and there is no known effective treatment This sort of infection will occur in between 10-30 of patients receiving a transplant from a donor who is not a perfect match and has been fatal in nearly all these cases
This infection occurs because the immune system cannot control the growth of the cells We want to see if we can prevent it from happening or treat it by giving the patient a kind of white blood cell called T cells that we have grown from the marrow donor These cells have been trained to attack EB virus infected cells We will grow these T cells from blood taken from the donor at the time of bone marrow harvest These T cells will be stimulated with the donors EB virus-infected cells which have been treated with radiation so they cannot grow After mixing these cells together we will be able to grow special T cells from the donor that can attack EB virus infected cells We will then collect the T cells and make sure they can kill the virus infected cells These EBV specific T cells are an investigational product not approved by the Food and Drug Administration
In normal people the Epstein-Barr EB virus infection causes a flu like illness and usually gets better when the immune system controls the infection The virus however remains hidden in the body for life After a transplant while the new immune system is growing back the EB virus can come out and infect cells and cause them to grow in an uncontrolled manner Patients can develop fevers swollen lymph nodes and damage to other organs such as kidneys and lungs This infection acts like a cancer because the cells infected with EB virus grow very quickly and there is no known effective treatment This sort of infection will occur in between 10-30 of patients receiving a transplant from a donor who is not a perfect match and has been fatal in nearly all these cases
This infection occurs because the immune system cannot control the growth of the cells We want to see if we can prevent it from happening or treat it by giving the patient a kind of white blood cell called T cells that we have grown from the marrow donor These cells have been trained to attack EB virus infected cells We will grow these T cells from blood taken from the donor at the time of bone marrow harvest These T cells will be stimulated with the donors EB virus-infected cells which have been treated with radiation so they cannot grow After mixing these cells together we will be able to grow special T cells from the donor that can attack EB virus infected cells We will then collect the T cells and make sure they can kill the virus infected cells These EBV specific T cells are an investigational product not approved by the Food and Drug Administration
Detailed Description:
We will obtain blood from the donor and will first make a B cell line called a lymphoblastoid cell line or LCL by infecting the blood with a laboratory strain of EBV called B95 We 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 We will then test the T cells to make sure that they kill the EBV infected cells and not the normal cells and freeze them
The marrow donors T cells will be thawed and injected through an intravenous line for a period of 10 minutes The subject may be premedicated with diphenhydramine Benadryl and acetaminophen Tylenol We would give one dose of the cells on or after day 45 following transplant if the subject agreed and was well enough If the EBV DNA levels remain high or the subject has persistent disease she may be eligible to receive up to 5 additional injections of T cells at the original dose at monthly intervals After the subject has received the T cells she will be contacted by the research nurse or another member of the study team weekly for 6 weeks then once every three months for a year so that we can check on hisher progress
We will continue to follow the subject in the BMT clinic after the injections To learn more about the way the T cells are working an extra 40 mls about 8 teaspoonfuls of blood will be taken pre-infusion 4 hours after the infusion 3-4 days post infusion optional and at 1 2 4 and 6 weeks after the T cell infusions and then at 3 6 9 and 12 months post infusion The blood should come from the central intravenous line and should not require extra needle sticks
The marrow donors T cells will be thawed and injected through an intravenous line for a period of 10 minutes The subject may be premedicated with diphenhydramine Benadryl and acetaminophen Tylenol We would give one dose of the cells on or after day 45 following transplant if the subject agreed and was well enough If the EBV DNA levels remain high or the subject has persistent disease she may be eligible to receive up to 5 additional injections of T cells at the original dose at monthly intervals After the subject has received the T cells she will be contacted by the research nurse or another member of the study team weekly for 6 weeks then once every three months for a year so that we can check on hisher progress
We will continue to follow the subject in the BMT clinic after the injections To learn more about the way the T cells are working an extra 40 mls about 8 teaspoonfuls of blood will be taken pre-infusion 4 hours after the infusion 3-4 days post infusion optional and at 1 2 4 and 6 weeks after the T cell infusions and then at 3 6 9 and 12 months post infusion The blood should come from the central intravenous line and should not require extra needle sticks
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 |
|---|---|---|---|
| ETNA | None | None | None |