Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001637
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
1999-11-03
Brief Title:
Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Low Intensity Preparative Regimen Followed by HLA-Matched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematologic Malignancies in Older Adults
Status:
COMPLETED
Status Verified Date:
2016-12-28
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:
Diseases such as leukemia lymphoma and multiple myeloma fall into the category of blood cancers Some of these conditions can now be cured by bone marrow transplantation BMT The ability of BMT to cure these conditions has been credited to the use of high doses of chemotherapy radiation therapy and the antileukemia effect of the transplant
Because the effectiveness of BMT relies on the use of high doses of chemotherapy and total body irradiation TBI it is a therapy associated with toxic side effects These side effects are often deadly and have limited BMT for use in patients under the age of 55
In this study researchers plan to treat older patients between the ages of 55 to 75 years with blood cell transplants taken from donors who are genetically matched relatives of the patient In order to decrease the toxic side effects associated with the transplant researchers will not use chemoradiotherapy Instead they plan to use intensive immunosuppressive therapy and allow the transplanted cells to take effect
Because the effectiveness of BMT relies on the use of high doses of chemotherapy and total body irradiation TBI it is a therapy associated with toxic side effects These side effects are often deadly and have limited BMT for use in patients under the age of 55
In this study researchers plan to treat older patients between the ages of 55 to 75 years with blood cell transplants taken from donors who are genetically matched relatives of the patient In order to decrease the toxic side effects associated with the transplant researchers will not use chemoradiotherapy Instead they plan to use intensive immunosuppressive therapy and allow the transplanted cells to take effect
Detailed Description:
Patients with adult leukemias non-Hodgkins lymphoma and multiple myeloma can now be cured by allogeneic bone marrow transplantation BMT This curative effect has been ascribed to the use of high dose chemoradiotherapy and the antileukemia effect of the graft
The assumption that BMT relies on the myeloablative effect of high dose chemotherapy and total body irradiation TBI has largely restricted allogeneic bone marrow transplantation in adults to those under the age of 55 years Toxicity related mortality increases progressively with age and although some transplant centers carry out BMT in patients up to the age of 60 years it is generally accepted that treatment related mortality prohibits the use of allogeneic bone marrow transplantation in patients beyond the age of 55 years
Several in vitro studies have demonstrated the existence of donor-derived CD4 and CD8 positive lymphocytes with specific reactivity for the patients leukemia and a potent graft versus leukemia GVL effect This GVL effect is best seen in patients with relapse CML after bone marrow transplantation where a single infusion of donor lymphocytes can induce complete remission
In this protocol we treat older patients between the ages of 55 to 71 years with hematologic disorders with an allogeneic stem cell transplant from an HLA identical sibling using intensive immunosuppressive regimen without myeloablation in attempts to decrease the transplant related toxicity while preserving the antileukemia effect of the graft The low intensity nonmyeloablative conditioning regimen will provide adequate immunosuppression to allow stem cell and lymphocyte engraftment T-cell replete donor-derived granulocyte colony stimulating factor G-CSF mobilized peripheral blood stem cells PBSC will be used to establish hematopoietic and lymphoid immune reconstitution We will add back lymphocytes in patients with less than 75 donor marrow chimerism as an attempt to prevent graft rejection
The end points of this study are engraftment degree of donor-host chimerism incidence of acute and chronic GVHD transplant related morbidity and mortality as well as survival
The assumption that BMT relies on the myeloablative effect of high dose chemotherapy and total body irradiation TBI has largely restricted allogeneic bone marrow transplantation in adults to those under the age of 55 years Toxicity related mortality increases progressively with age and although some transplant centers carry out BMT in patients up to the age of 60 years it is generally accepted that treatment related mortality prohibits the use of allogeneic bone marrow transplantation in patients beyond the age of 55 years
Several in vitro studies have demonstrated the existence of donor-derived CD4 and CD8 positive lymphocytes with specific reactivity for the patients leukemia and a potent graft versus leukemia GVL effect This GVL effect is best seen in patients with relapse CML after bone marrow transplantation where a single infusion of donor lymphocytes can induce complete remission
In this protocol we treat older patients between the ages of 55 to 71 years with hematologic disorders with an allogeneic stem cell transplant from an HLA identical sibling using intensive immunosuppressive regimen without myeloablation in attempts to decrease the transplant related toxicity while preserving the antileukemia effect of the graft The low intensity nonmyeloablative conditioning regimen will provide adequate immunosuppression to allow stem cell and lymphocyte engraftment T-cell replete donor-derived granulocyte colony stimulating factor G-CSF mobilized peripheral blood stem cells PBSC will be used to establish hematopoietic and lymphoid immune reconstitution We will add back lymphocytes in patients with less than 75 donor marrow chimerism as an attempt to prevent graft rejection
The end points of this study are engraftment degree of donor-host chimerism incidence of acute and chronic GVHD transplant related morbidity and mortality as well as survival
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-H-0202 | None | None | None |