Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00469820
Status:
TERMINATED
Last Update Posted:
2014-03-21
First Post:
2007-05-03
Brief Title:
Vaccine Therapy With or Without Donor Lymphocyte Infusion in Treating Patients With Acute Myeloid Leukemia Acute Lymphoblastic Leukemia or Multiple Myeloma Undergoing Donor Stem Cell Transplant
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Posttransplant Immunotherapy With Donor Lymphocyte Infusions and Autologous Tumor Vaccines After HLA-Matched Transplant
Status:
TERMINATED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vaccines made from the patients cancer cells may help the body build an effective immune response to kill cancer cells Giving vaccine therapy together with donor lymphocyte infusion after a stem cell transplant from the patients brother or sister may kill any cancer cells that remain after transplant
PURPOSE This clinical trial is studying the side effects best dose and how well vaccine therapy with or without donor lymphocyte infusion works in treating patients with acute myeloid leukemia acute lymphoblastic leukemia or multiple myeloma undergoing donor stem cell transplant
PURPOSE This clinical trial is studying the side effects best dose and how well vaccine therapy with or without donor lymphocyte infusion works in treating patients with acute myeloid leukemia acute lymphoblastic leukemia or multiple myeloma undergoing donor stem cell transplant
Detailed Description:
OBJECTIVES
Determine time to relapse and overall survival of patients with high-risk acute myeloid leukemia acute lymphoblastic leukemia or multiple myeloma treated with autologous tumor cell vaccine with or without donor lymphocyte infusion after HLA-matched related sibling nonmyeloablative hematopoietic stem cell transplantation
Evaluate the safety and tolerability of this regimen in these patients
Determine the maximum tolerated dose of donor lymphocyte infusions in these patients
OUTLINE Patients undergo collection of tumor cells for production of the cancer cell vaccine and then undergo HLA-matched related sibling nonmyeloablative hematopoietic stem cell transplantation HSCT Patients then receive cancer cell vaccine with or without donor lymphocyte infusion The donor lymphocytes are obtained from the same relative who donated stem cells for the HSCT
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Determine time to relapse and overall survival of patients with high-risk acute myeloid leukemia acute lymphoblastic leukemia or multiple myeloma treated with autologous tumor cell vaccine with or without donor lymphocyte infusion after HLA-matched related sibling nonmyeloablative hematopoietic stem cell transplantation
Evaluate the safety and tolerability of this regimen in these patients
Determine the maximum tolerated dose of donor lymphocyte infusions in these patients
OUTLINE Patients undergo collection of tumor cells for production of the cancer cell vaccine and then undergo HLA-matched related sibling nonmyeloablative hematopoietic stem cell transplantation HSCT Patients then receive cancer cell vaccine with or without donor lymphocyte infusion The donor lymphocytes are obtained from the same relative who donated stem cells for the HSCT
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| P01CA015396 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| JHOC-J06118 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |