Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038883
Status:
TERMINATED
Last Update Posted:
2018-11-07
First Post:
2002-06-05
Brief Title:
Campath-1H and Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Campath-1H Snd Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies
Status:
TERMINATED
Status Verified Date:
2018-11
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:
None
Brief Summary:
High dose chemotherapy followed by transplantation of allogeneic hematopoietic stem cell with the use of Campath-1h a monoclonal antibody that have a synergistic effect to chemotherapy with minimal toxicity In addition Campath-1H can improve engraftment of donor cells through its immunosuppressive properties
Detailed Description:
Alemtuzumab is a drug that is designed to specifically attack some types of leukemia and lymphoma cells In addition it weakens the immune system helping to prevent the rejection of donor marrow or stem cells
If you are found to be eligible to take part in this study you will be admitted to the hospital for treatment Alemtuzumab will be injected into your vein over a period of 4 hours This will be done 5 days in a row Days 1 to 5 Drugs diphenhydramine Benadryl solumedrol and acetaminophen Tylenol will be given in to decrease the risk of or ease side effects before each dose of the alemtuzumab
You will also receive Carmustine over one hour on the first day From the second to the fifth day you will receive cytarabine and etoposide twice a day On the six day you will receive melphalan once Both 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 on this study Some participants depending on their type of disease will also receive rituximab Rituximab will be given during the first day of chemotherapy then once a week for a total of 4 doses
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 your blood cell counts recover to a certain level
Blood tests about 2 tablespoons each urine tests bone marrow aspirations and x-rays will be done as needed to track the effects of the transplant The blood tests will be drawn daily while in the hospital and then at least twice weekly as an outpatient for the first 100 days The CT scans and bone marrow studies will be done at 1 3 6 and 12 months and then every 6 months for at least 3 years after transplant You may also have transfusions of blood and platelets as needed
You will need to stay in the hospital about 3 to 4 weeks You will be taken off study if their disease gets worse or intolerable side effects occur You must stay in the Houston area for about 100 days after the transplant After that you will be asked to return to Houston every 6 months for the next 3-5 years for scans CT gallium or PET scans and bone marrow aspirations over the next 3-5 years
This is an investigational study The FDA has approved the drugs used in this study Their use together in this study is investigational About 142 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 be admitted to the hospital for treatment Alemtuzumab will be injected into your vein over a period of 4 hours This will be done 5 days in a row Days 1 to 5 Drugs diphenhydramine Benadryl solumedrol and acetaminophen Tylenol will be given in to decrease the risk of or ease side effects before each dose of the alemtuzumab
You will also receive Carmustine over one hour on the first day From the second to the fifth day you will receive cytarabine and etoposide twice a day On the six day you will receive melphalan once Both 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 on this study Some participants depending on their type of disease will also receive rituximab Rituximab will be given during the first day of chemotherapy then once a week for a total of 4 doses
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 your blood cell counts recover to a certain level
Blood tests about 2 tablespoons each urine tests bone marrow aspirations and x-rays will be done as needed to track the effects of the transplant The blood tests will be drawn daily while in the hospital and then at least twice weekly as an outpatient for the first 100 days The CT scans and bone marrow studies will be done at 1 3 6 and 12 months and then every 6 months for at least 3 years after transplant You may also have transfusions of blood and platelets as needed
You will need to stay in the hospital about 3 to 4 weeks You will be taken off study if their disease gets worse or intolerable side effects occur You must stay in the Houston area for about 100 days after the transplant After that you will be asked to return to Houston every 6 months for the next 3-5 years for scans CT gallium or PET scans and bone marrow aspirations over the next 3-5 years
This is an investigational study The FDA has approved the drugs used in this study Their use together in this study is investigational About 142 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