Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068718
Status:
COMPLETED
Last Update Posted:
2020-01-31
First Post:
2003-09-10
Brief Title:
Donor Lymphocyte Infusion in Treating Patients With Persistent Relapsed or Progressing Cancer After Donor Hematopoietic Cell Transplant
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Donor Lymphocyte Infusion for the Treatment of Malignancy After Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning - A Multi-center Trial
Status:
COMPLETED
Status Verified Date:
2020-01
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 phase III trial studies the side effects of donor lymphocyte infusion and to see how well it works in treating patients with persistent relapsed disease that has returned or progressing cancer after donor hematopoietic cell transplantation White blood cells from donors may be able to kill cancer cells in patients with cancer that has come back recurrent after a donor hematopoietic cell transplant
Detailed Description:
PRIMARY OBJECTIVES
I To assess the safety of donor lymphocyte infusion DLI as adoptive immunotherapy for persistent or relapsed malignant diseases in patients after related or unrelated nonmyeloablative transplantation
SECONDARY OBJECTIVES
I To determine disease response progression free and overall survival chimerism grade of graft-versus-host disease GVHD and infections
OUTLINE
Patients undergo unirradiated DLI over 15-30 minutes on day 0 Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented
After completion of study treatment patients are followed up periodically
I To assess the safety of donor lymphocyte infusion DLI as adoptive immunotherapy for persistent or relapsed malignant diseases in patients after related or unrelated nonmyeloablative transplantation
SECONDARY OBJECTIVES
I To determine disease response progression free and overall survival chimerism grade of graft-versus-host disease GVHD and infections
OUTLINE
Patients undergo unirradiated DLI over 15-30 minutes on day 0 Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented
After completion of study treatment patients are followed up periodically
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 |
|---|---|---|---|
| P30CA015704 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |
| NCI-2010-00163 | REGISTRY | None | None |
| 180300 | OTHER | None | None |
| P01CA078902 | NIH | None | None |