Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473551
Status:
TERMINATED
Last Update Posted:
2011-12-19
First Post:
2007-05-11
Brief Title:
Anti-Third Party T Lymphocytes With Nonmyeloablative Stem Cell Transplantation for Indolent Lymphoid Malignancies
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Anti-Third Party T Lymphocytes With Nonmyeloablative Stem Cell Transplantation for Treatment of Indolent Lymphoid Malignancies
Status:
TERMINATED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
1 To determine the maximally tolerated dose of anti-third party cytolytic T-lymphocytes defined as the dose which achieve engraftment without severe GVHD graft-vs-host disease at 90 days after allogeneic transplantation of CD34 hematopoietic progenitor cells
Secondary Objective
1 Toxicity response rate time to progression and overall survival
1 To determine the maximally tolerated dose of anti-third party cytolytic T-lymphocytes defined as the dose which achieve engraftment without severe GVHD graft-vs-host disease at 90 days after allogeneic transplantation of CD34 hematopoietic progenitor cells
Secondary Objective
1 Toxicity response rate time to progression and overall survival
Detailed Description:
GVHD can be a major problem after stem cell transplantation from a healthy donor It is caused by T-lymphocytes a type of immune cell from the donor that can react badly against the person receiving the transplant the recipient Researchers want to see if stimulating the donor T-lymphocytes against another person a third party and growing them for 28 days will decrease the chance of developing GVHD
If you are found to be eligible to take part in this study you will receive the below treatment including chemotherapy and radiation before your stem cell transplantation These include rituximab cyclophosphamide fludarabine and mesna Rituximab is designed to attach to lymphoma cells causing them to die Cyclophosphamide is designed to destroy cancer cells by interfering with their multiplication and slowing or stopping their growth and spread throughout the body Fludarabine is designed to interfere with DNA repair enzymes so that the leukemic cell cannot repair damaged DNA This increases the likelihood of the cell dying Mesna is a drug that lowers the risk of bladder side effects by the cyclophosphamide Total body radiation is given to to reduce the risk of transplant rejection
Participants with CLL or lymphoma will receive Rituxan rituximab by vein given over several hours for each dose The first rituximab dose is 13 days before the transplant This will be followed by 3 more doses of rituximab given 6 days before the transplant and 1 and 8 days after the transplant All participants will receive fludarabine by vein over 30 minutes once per day for 4 days starting 6 days before the transplant All participants will also receive cyclophosphamide by vein over 2 hours The cyclophosphamide will be given immediately after the first dose of fludarabine All participants will also receive a continuous infusion of mesna by vein for 24 hours after receiving the cyclophosphamide One day before transplantation you will have total body radiation
After receiving total body radiation you will receive your stem cell transplantation On the day of the transplant you will receive the anti-third party T Lymphocytes CTLs by vein This will be followed by vein infusion of stem cells from the donor A sample of the anti-third party T-cells cells will also be tested for immune function
All participants will receive sirolimus by mouth for 10 days starting 2 days before transplantation Sirolimus is an immunosuppressive drug which is given to reduce the risk of transplant rejection You will remain in the hospital for about 4 weeks after the transplant You will then continue as an outpatient in the Houston area for 100 days after your transplantation or until your doctor feels it is okay for you to leave the Houston area
If your disease gets worse after your transplantation you may receive additional immune cells from the donor DLI-donor lymphocyte infusionYou may be taken off this study if the transplant does not grow or is rejected if not enough of the CTLs can be produced if your disease continues to get worse after receiving additional donors cells or if you experience any intolerable side effects
You will have frequent blood tests as medically necessary to evaluate your medical condition About 3 tablespoons of blood will be collected for immune function testing at 1 2 3 6 and 12 months after the transplant You will have a bone marrow biopsy x-rays and CT scans for evaluation of the cancer at 1 3 6 9 and 12 months after the transplant The study is over after 1 year You will be followed-up after that time for routine care as the doctors feels it is necessary
This is an investigational study All of the drugs used in this study have been approved by the FDA in the treatment of cancer and transplantation The Miltenyi CliniMACS System which is used to purify stem cells and the anti-third party CTLs has not been approved by the FDA and its use in this study is experimental Up to 24 patients will take part in this study All will be enrolled at M D Anderson
If you are found to be eligible to take part in this study you will receive the below treatment including chemotherapy and radiation before your stem cell transplantation These include rituximab cyclophosphamide fludarabine and mesna Rituximab is designed to attach to lymphoma cells causing them to die Cyclophosphamide is designed to destroy cancer cells by interfering with their multiplication and slowing or stopping their growth and spread throughout the body Fludarabine is designed to interfere with DNA repair enzymes so that the leukemic cell cannot repair damaged DNA This increases the likelihood of the cell dying Mesna is a drug that lowers the risk of bladder side effects by the cyclophosphamide Total body radiation is given to to reduce the risk of transplant rejection
Participants with CLL or lymphoma will receive Rituxan rituximab by vein given over several hours for each dose The first rituximab dose is 13 days before the transplant This will be followed by 3 more doses of rituximab given 6 days before the transplant and 1 and 8 days after the transplant All participants will receive fludarabine by vein over 30 minutes once per day for 4 days starting 6 days before the transplant All participants will also receive cyclophosphamide by vein over 2 hours The cyclophosphamide will be given immediately after the first dose of fludarabine All participants will also receive a continuous infusion of mesna by vein for 24 hours after receiving the cyclophosphamide One day before transplantation you will have total body radiation
After receiving total body radiation you will receive your stem cell transplantation On the day of the transplant you will receive the anti-third party T Lymphocytes CTLs by vein This will be followed by vein infusion of stem cells from the donor A sample of the anti-third party T-cells cells will also be tested for immune function
All participants will receive sirolimus by mouth for 10 days starting 2 days before transplantation Sirolimus is an immunosuppressive drug which is given to reduce the risk of transplant rejection You will remain in the hospital for about 4 weeks after the transplant You will then continue as an outpatient in the Houston area for 100 days after your transplantation or until your doctor feels it is okay for you to leave the Houston area
If your disease gets worse after your transplantation you may receive additional immune cells from the donor DLI-donor lymphocyte infusionYou may be taken off this study if the transplant does not grow or is rejected if not enough of the CTLs can be produced if your disease continues to get worse after receiving additional donors cells or if you experience any intolerable side effects
You will have frequent blood tests as medically necessary to evaluate your medical condition About 3 tablespoons of blood will be collected for immune function testing at 1 2 3 6 and 12 months after the transplant You will have a bone marrow biopsy x-rays and CT scans for evaluation of the cancer at 1 3 6 9 and 12 months after the transplant The study is over after 1 year You will be followed-up after that time for routine care as the doctors feels it is necessary
This is an investigational study All of the drugs used in this study have been approved by the FDA in the treatment of cancer and transplantation The Miltenyi CliniMACS System which is used to purify stem cells and the anti-third party CTLs has not been approved by the FDA and its use in this study is experimental Up to 24 patients will take part in this study All will be enrolled at M D Anderson
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