Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00143884
Status:
TERMINATED
Last Update Posted:
2007-04-23
First Post:
2005-08-31
Brief Title:
Study of Low Intensity Conditioning and Immunotherapy for High-Risk Cancers of the Blood
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Adjuvant Cellular Immunotherapy for High-Risk Hematologic Malignancy After Allogeneic Stem Cell Transplantation Using Low Intensity Conditioning
Status:
TERMINATED
Status Verified Date:
2007-01
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:
None
Brief Summary:
This research project will focus on whether it is safe and effective to rely on donor cells to prevent relapse of leukemia lymphoma or other blood cancer after bone marrow stem cell transplant
Detailed Description:
This research project will focus on whether it is safe and effective to rely on donor cells to prevent relapse of leukemia lymphoma or other blood cancer after bone marrow stem cell transplant SCT For many patients with these conditions a bone marrow transplant can be the only chance for cure The standard type of bone marrow transplant involves giving very high-doses of chemotherapy and radiation to kill all the cancer cells followed by an infusion of bone marrow stem cells from a relative who is a bone marrow match After the transplant the patient takes anti-rejection drugs for many months to prevent the donors immune cells from causing a severe reaction called Graft-versus-Host Disease GVHD which can even be fatal However for some patients with certain types of high-risk cancer even this intense treatment is not effective and the cancer relapses
Is has been known for many years that some of the bone marrow cells from the donor can kill cancer cells Recently it has been discovered that sometimes patients who relapse after a bone marrow SCT can be cured by giving an infusion of donor white blood cells called a donor leukocyte infusion or DLI By giving a DLI BEFORE a relapse happens hopefully relapse can be prevented
The high doses of chemotherapy and radiation therapy given prior to a standard bone marrow stem cell transplant can make a patient very sick and also increase the chance of getting severe GVHD In this research study we are going to rely mainly on the donor cells to kill the cancer cells and patients will receive dosages of chemotherapy that are lower than the usual dosages It is thought that this low intensity conditioning will make the transplant safer without risking more relapses however it is not know whether low intensity conditioning is safer than standard conditioning
Is has been known for many years that some of the bone marrow cells from the donor can kill cancer cells Recently it has been discovered that sometimes patients who relapse after a bone marrow SCT can be cured by giving an infusion of donor white blood cells called a donor leukocyte infusion or DLI By giving a DLI BEFORE a relapse happens hopefully relapse can be prevented
The high doses of chemotherapy and radiation therapy given prior to a standard bone marrow stem cell transplant can make a patient very sick and also increase the chance of getting severe GVHD In this research study we are going to rely mainly on the donor cells to kill the cancer cells and patients will receive dosages of chemotherapy that are lower than the usual dosages It is thought that this low intensity conditioning will make the transplant safer without risking more relapses however it is not know whether low intensity conditioning is safer than standard conditioning
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