Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505921
Status:
TERMINATED
Last Update Posted:
2011-11-16
First Post:
2007-07-20
Brief Title:
Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Autologous and Allogeneic Transplantation for T-Cell Lymphoma Impact of Campath -1H and Soluble CD52
Status:
TERMINATED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objectives
1 To evaluate the role of autologous and allogenic stem cell transplantation with Campath-1H for patients with peripheral T-cell lymphoma PTCL
2 To examine the impact of in-vivo purging with Campath -1H pre-autologous stem transplantation for patients with PTCL
3 To evaluate the impact of soluble CD52 upon in-vivo purging with Campath-1H
4 To evaluate the role of Campath -1H in the treatment minimal residual disease after autologous transplantation for PTCL
1 To evaluate the role of autologous and allogenic stem cell transplantation with Campath-1H for patients with peripheral T-cell lymphoma PTCL
2 To examine the impact of in-vivo purging with Campath -1H pre-autologous stem transplantation for patients with PTCL
3 To evaluate the impact of soluble CD52 upon in-vivo purging with Campath-1H
4 To evaluate the role of Campath -1H in the treatment minimal residual disease after autologous transplantation for PTCL
Detailed Description:
Campath is a drug that can specifically attack some types of T-cell lymphoma cells
Before the study begins you will have a physical exam including blood about 2 tablespoons and urine tests Women who are able to have children must have a negative blood pregnancy test Bone marrow samples will be taken To collect a bone marrow sample an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone marrow is withdrawn through a large needle Patients will have a chest x-ray an EKG test to measure the electrical activity of the heart and tests of lung function Patients whose disease affects the stomach or intestines may have biopsies of these areas
Treatment will be given in the hospital at M D Anderson You will need to stay in the hospital for about 3 to 4 weeks
A central venous catheter plastic tube will be placed into the large chest vein The catheter will be left in place throughout treatment In order to collect stem cells G-CSF and GM-CSF will be injected under the skin This will be done twice a day until the collection of stem cells is complete You will receive Campath -1H through the catheter on Days 1 2 3 and 10 of chemotherapy treatment
The stem cells will be collected from you starting about 10 to 14 days after chemotherapy is given The collection process is called apheresis Blood is removed from the your body and the stem cells are frozen for storage Stem cell collection takes about 3 hours Between 3 and 5 sessions may be needed to collect enough stem cells Sessions will be done once a day
After stem cells are collected you will receive high dose Carmustine over 1 hour on Day 1 You will receive cytarabine and etoposide twice a day on Days 2 through 5 and melphalan on Day 6
One day after finishing the chemotherapy the stem cells that were collected earlier will be infused back into you over about 30 minutes G-CSF and GM-CSF will be injected until your white blood cell counts returns to normal
Blood tests 1-2 tablespoons urine tests bone marrow sampling and x-rays will be done as needed to track the effects of the transplant You will have transfusions of blood and platelets as needed Blood tests 1-2 tablespoons will be done daily while you are in the hospital
You might have to stay in the Houston area for 2 to 4 weeks after the transplant After that you will need to return to Houston every 3 months for the first year then every 6 months for 5 years Three months after the transplant bone marrow exams and other tests will be done If you show evidence of disease you will receive another cycle of Campath -1H three times a week for 4-12 weeks Patients will be taken off study if the disease gets worse or intolerable side effects occur
This is an investigational study The FDA has approved the drugs used in this study Their use together in this study is investigational About 30 patients will take part in this study All will be enrolled at M D Anderson
Nonmyeloablative Allogeneic Transplantation with Campath-1H for T-cell Lymphoma
Campath is a drug that can specifically attack some types of T-cell lymphoma cells In addition it weakens the immune system therefore helping to prevent the rejection of donor marrow or stem cells
TBI is designed to damage the DNA the genetic material of cells of cancer cells which may kill the cancer cells
Cyclophosphamide is designed to interfere with the multiplication of cancer cells which may slow or stop their growth and spread throughout the body This may cause the cancer cells to die
Fludarabine is designed to make cancer cells less able to repair damaged DNA This may increase the likelihood of the cells dying
Before the study begins you will have a physical exam including blood about 1-2 tablespoons and urine tests Women who are able to have children must have a negative blood pregnancy test Bone marrow samples will be taken To collect a bone marrow sample an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone marrow is withdrawn through a large needle You will have a chest x-ray CT scans an EKG test to measure the electrical activity of the heart and tests of lung function
Blood tests 1-2 tablespoons urine tests bone marrow sampling and x-rays will be done as needed to track the effects of the transplant Patients will have transfusions of blood and platelets as needed Blood tests 1-2 tablespoons will be done daily while you are in the hospital
Campath-1 H will be injected into your vein This will be done 3 days in a row Days 1 to 3 The drugs diphenhydramine Benadryl acetaminophen Tylenol and hydrocortisone will be given in to decrease the risk of or ease side effects
You will also receive fludarabine and cyclophosphamide daily for 3 days They will be given starting day of Campath -1H
All of the chemotherapy drugs will be given through a catheter plastic tube that extends into the large chest vein The catheter will be left in place throughout treatment After completion of chemotherapy you will receive TBI and later on the same day blood stem cells from a donor will be given through the catheter G-CSF and GM-CSF growth factors that promote the production of blood cells will be injected under the skin once a day until the neutrophil counts recover in the blood
Tacrolimus will be infused through the vein starting 2 days before transplant to decrease the risk of graft-versus-host disease It will be changed to pills after you are discharged from the hospital For the same purpose methotrexate will also be given through the vein on Days 1 3 6 and Day 11 if unrelated donor
Treatment will be given in the hospital at UTMDACC You will need to stay in the hospital for about 3 to 4 weeks
You must stay in the Houston area for about 100 days after the transplant After that you will need to return to Houston every three months for the first year then every 6 months for 5 years for blood tests 1-2 tablespoons urine tests and CT scans Bone marrow aspirations and biopsies will also be performed Patients will be taken off study if the intolerable side effects occur
This is an investigational study The FDA has approved the drugs used in this study Their use together in this study is investigational About 30 patients will take part in this study All will be enrolled at UTMDACC
Before the study begins you will have a physical exam including blood about 2 tablespoons and urine tests Women who are able to have children must have a negative blood pregnancy test Bone marrow samples will be taken To collect a bone marrow sample an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone marrow is withdrawn through a large needle Patients will have a chest x-ray an EKG test to measure the electrical activity of the heart and tests of lung function Patients whose disease affects the stomach or intestines may have biopsies of these areas
Treatment will be given in the hospital at M D Anderson You will need to stay in the hospital for about 3 to 4 weeks
A central venous catheter plastic tube will be placed into the large chest vein The catheter will be left in place throughout treatment In order to collect stem cells G-CSF and GM-CSF will be injected under the skin This will be done twice a day until the collection of stem cells is complete You will receive Campath -1H through the catheter on Days 1 2 3 and 10 of chemotherapy treatment
The stem cells will be collected from you starting about 10 to 14 days after chemotherapy is given The collection process is called apheresis Blood is removed from the your body and the stem cells are frozen for storage Stem cell collection takes about 3 hours Between 3 and 5 sessions may be needed to collect enough stem cells Sessions will be done once a day
After stem cells are collected you will receive high dose Carmustine over 1 hour on Day 1 You will receive cytarabine and etoposide twice a day on Days 2 through 5 and melphalan on Day 6
One day after finishing the chemotherapy the stem cells that were collected earlier will be infused back into you over about 30 minutes G-CSF and GM-CSF will be injected until your white blood cell counts returns to normal
Blood tests 1-2 tablespoons urine tests bone marrow sampling and x-rays will be done as needed to track the effects of the transplant You will have transfusions of blood and platelets as needed Blood tests 1-2 tablespoons will be done daily while you are in the hospital
You might have to stay in the Houston area for 2 to 4 weeks after the transplant After that you will need to return to Houston every 3 months for the first year then every 6 months for 5 years Three months after the transplant bone marrow exams and other tests will be done If you show evidence of disease you will receive another cycle of Campath -1H three times a week for 4-12 weeks Patients will be taken off study if the disease gets worse or intolerable side effects occur
This is an investigational study The FDA has approved the drugs used in this study Their use together in this study is investigational About 30 patients will take part in this study All will be enrolled at M D Anderson
Nonmyeloablative Allogeneic Transplantation with Campath-1H for T-cell Lymphoma
Campath is a drug that can specifically attack some types of T-cell lymphoma cells In addition it weakens the immune system therefore helping to prevent the rejection of donor marrow or stem cells
TBI is designed to damage the DNA the genetic material of cells of cancer cells which may kill the cancer cells
Cyclophosphamide is designed to interfere with the multiplication of cancer cells which may slow or stop their growth and spread throughout the body This may cause the cancer cells to die
Fludarabine is designed to make cancer cells less able to repair damaged DNA This may increase the likelihood of the cells dying
Before the study begins you will have a physical exam including blood about 1-2 tablespoons and urine tests Women who are able to have children must have a negative blood pregnancy test Bone marrow samples will be taken To collect a bone marrow sample an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone marrow is withdrawn through a large needle You will have a chest x-ray CT scans an EKG test to measure the electrical activity of the heart and tests of lung function
Blood tests 1-2 tablespoons urine tests bone marrow sampling and x-rays will be done as needed to track the effects of the transplant Patients will have transfusions of blood and platelets as needed Blood tests 1-2 tablespoons will be done daily while you are in the hospital
Campath-1 H will be injected into your vein This will be done 3 days in a row Days 1 to 3 The drugs diphenhydramine Benadryl acetaminophen Tylenol and hydrocortisone will be given in to decrease the risk of or ease side effects
You will also receive fludarabine and cyclophosphamide daily for 3 days They will be given starting day of Campath -1H
All of the chemotherapy drugs will be given through a catheter plastic tube that extends into the large chest vein The catheter will be left in place throughout treatment After completion of chemotherapy you will receive TBI and later on the same day blood stem cells from a donor will be given through the catheter G-CSF and GM-CSF growth factors that promote the production of blood cells will be injected under the skin once a day until the neutrophil counts recover in the blood
Tacrolimus will be infused through the vein starting 2 days before transplant to decrease the risk of graft-versus-host disease It will be changed to pills after you are discharged from the hospital For the same purpose methotrexate will also be given through the vein on Days 1 3 6 and Day 11 if unrelated donor
Treatment will be given in the hospital at UTMDACC You will need to stay in the hospital for about 3 to 4 weeks
You must stay in the Houston area for about 100 days after the transplant After that you will need to return to Houston every three months for the first year then every 6 months for 5 years for blood tests 1-2 tablespoons urine tests and CT scans Bone marrow aspirations and biopsies will also be performed Patients will be taken off study if the intolerable side effects occur
This is an investigational study The FDA has approved the drugs used in this study Their use together in this study is investigational About 30 patients will take part in this study All will be enrolled at UTMDACC
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