Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052598
Status:
TERMINATED
Last Update Posted:
2017-02-15
First Post:
2003-01-24
Brief Title:
Therapeutic Allogeneic Lymphocytes and Aldesleukin in Treating Patients With High-Risk or Recurrent Myeloid Leukemia After Undergoing Donor Stem Cell Transplant
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Phase III Study of Adoptive Immunotherapy With CD8 Proteinase 3 Myeloblastin-Specific CTL Clones for HLA-A2 Patients With Relapse or Progression of Disease After Allogeneic Hematopoietic Stem Cell Transplant for High Risk Myeloid Leukemias
Status:
TERMINATED
Status Verified Date:
2017-02
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 is studies the side effects of giving therapeutic allogeneic lymphocytes together with aldesleukin and to see how well it works in treating patients with high-risk or recurrent myeloid leukemia after undergoing donor stem cell transplant Biological therapies such as therapeutic autologous lymphocytes may stimulate the immune system in different ways and stop cancer cells from growing Aldesleukin may stimulate the white blood cells to kill cancer cells Giving therapeutic autologous lymphocytes together with aldesleukin may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the safety and potential toxicities associated with infusing donor CD8 cytotoxic T lymphocytes CTL clones specific for Proteinase 3 Myeloblastin in patients with relapseprogression of high risk myeloid leukemias after transplant
SECONDARY OBJECTIVES
I To determine the in vivo persistence of transferred T cells and assess migration to the bone marrow a predominant site of leukemic relapse
II To determine if adoptively transferred proteinase 3 PR3-specific T cells mediate antileukemic activity
OUTLINE
Patients receive allogeneic CD8 PR3-specific CTLs intravenously IV over 1-2 hours on days 0 7 14 28 and 49 and aldesleukin subcutaneously SC twice daily on days 28-41 and 49-63 in the absence of unacceptable toxicity
After completion of study treatment patients are followed up every 1-3 months
I To determine the safety and potential toxicities associated with infusing donor CD8 cytotoxic T lymphocytes CTL clones specific for Proteinase 3 Myeloblastin in patients with relapseprogression of high risk myeloid leukemias after transplant
SECONDARY OBJECTIVES
I To determine the in vivo persistence of transferred T cells and assess migration to the bone marrow a predominant site of leukemic relapse
II To determine if adoptively transferred proteinase 3 PR3-specific T cells mediate antileukemic activity
OUTLINE
Patients receive allogeneic CD8 PR3-specific CTLs intravenously IV over 1-2 hours on days 0 7 14 28 and 49 and aldesleukin subcutaneously SC twice daily on days 28-41 and 49-63 in the absence of unacceptable toxicity
After completion of study treatment patients are followed up every 1-3 months
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 |
|---|---|---|---|
| P01CA018029 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchP01CA018029 |
| NCI-2010-00826 | REGISTRY | None | None |