Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038844
Status:
COMPLETED
Last Update Posted:
2011-11-02
First Post:
2002-06-05
Brief Title:
Safety and Efficacy of Campath in Nonmyeloablative Transplantation
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Safety and Efficacy of Campath in Nonmyeloablative Transplantation
Status:
COMPLETED
Status Verified Date:
2011-10
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:
Objective of the low-dose transplant regimen must produce the following effects
1 Suppression of the patients immune system to prevent rejection of the donor cells
2 Control of the lymphoma The pretransplant regimen must suppress the lymphoma sufficiently to prevent marked progression of the tumor and allow time for the GVT effect to occur
1 Suppression of the patients immune system to prevent rejection of the donor cells
2 Control of the lymphoma The pretransplant regimen must suppress the lymphoma sufficiently to prevent marked progression of the tumor and allow time for the GVT effect to occur
Detailed Description:
Alemtuzumab is a drug that can specifically attack some types of leukemia and lymphoma cells In addition it suppresses the patients immune system therefore helps preventing the rejection of donor marrow or stem cells
Before treatment starts patients will have a physical exam including blood tests between 100 - 120 cc and urine tests Women who are able to have children will have a pregnancy test Bone marrow samples will be taken Patients will have a chest x-ray CT scans and EKG and tests of lung function
Blood tests between 100 - 120 cc marrow sampling and x-rays will be done as needed to track the effects of the transplant For bone marrow sampling a large needle is placed into the numbed hipbone The bone marrow is then withdrawn through the needle Patients will have transfusions of blood and platelets as needed Blood tests between 100 - 120 cc will be done daily while patients are in the hospital
Alemtuzumab will be injected into the patients vein This will be done 3 days in a row days 1 to 3 The drugs diphenhydramine Benadryl and acetaminophen Tylenol will be given in to prevent or ease side effects
Patients will also receive fludarabine and cyclophosphamide daily for 3 days They will be given on the same days as alemtuzumab Rituximab will be given to some patients only based on the subtypes of lymphomas eight days before the transplant and then weekly for a total of 4 doses
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 When chemotherapy is finished blood stem cells from a donor will be given through the catheter G-CSF a growth factor that promotes the production of blood cells will be injected under the skin once a day until the neutrophil counts recover in the blood
A boost of donor cells lymphocytes will be given at 3 months after transplant if the disease is getting worse or if DNA tests from the blood shows that not all lymphocytes in the blood are from the donor These cells will be given through the vein without chemotherapy in the clinic
Treatment will be given in the hospital at M D Anderson Patients will need to stay in the hospital for about 3 to 4 weeks Patients will be taken off study if their disease progresses
Patients must stay in the Houston area for about 100 days after the transplant After that patients will need to return to Houston from time to time for blood tests urine tests and other exams
This is an investigational study The FDA has approved the drugs used in this study Their use together in this study is investigational About 100 patients will take part in this study All will be enrolled at M D Anderson
Before treatment starts patients will have a physical exam including blood tests between 100 - 120 cc and urine tests Women who are able to have children will have a pregnancy test Bone marrow samples will be taken Patients will have a chest x-ray CT scans and EKG and tests of lung function
Blood tests between 100 - 120 cc marrow sampling and x-rays will be done as needed to track the effects of the transplant For bone marrow sampling a large needle is placed into the numbed hipbone The bone marrow is then withdrawn through the needle Patients will have transfusions of blood and platelets as needed Blood tests between 100 - 120 cc will be done daily while patients are in the hospital
Alemtuzumab will be injected into the patients vein This will be done 3 days in a row days 1 to 3 The drugs diphenhydramine Benadryl and acetaminophen Tylenol will be given in to prevent or ease side effects
Patients will also receive fludarabine and cyclophosphamide daily for 3 days They will be given on the same days as alemtuzumab Rituximab will be given to some patients only based on the subtypes of lymphomas eight days before the transplant and then weekly for a total of 4 doses
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 When chemotherapy is finished blood stem cells from a donor will be given through the catheter G-CSF a growth factor that promotes the production of blood cells will be injected under the skin once a day until the neutrophil counts recover in the blood
A boost of donor cells lymphocytes will be given at 3 months after transplant if the disease is getting worse or if DNA tests from the blood shows that not all lymphocytes in the blood are from the donor These cells will be given through the vein without chemotherapy in the clinic
Treatment will be given in the hospital at M D Anderson Patients will need to stay in the hospital for about 3 to 4 weeks Patients will be taken off study if their disease progresses
Patients must stay in the Houston area for about 100 days after the transplant After that patients will need to return to Houston from time to time for blood tests urine tests and other exams
This is an investigational study The FDA has approved the drugs used in this study Their use together in this study is investigational About 100 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