Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052520
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2003-01-24
Brief Title:
Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome Acute or Chronic Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Phase III Study of Adoptive Immunotherapy With CD8 WT1-Specific CTL Clones for Patients With Advanced MDS CML AML or ALL After Allogeneic Hematopoietic Stem Cell Transplant
Status:
COMPLETED
Status Verified Date:
2013-07
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 studying the side effects of biological therapy and to see how well it works in treating patients with advanced myelodysplastic syndrome chronic myeloid leukemia acute myeloid leukemia or acute lymphoblastic leukemia Biological therapies including immunotherapy can potentially be used to stimulate the immune system and stop cancer cells from growing Immunotherapy given to patients who have undergone donor stem cell transplantation may be a way to eradicate remaining cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the safety and potential toxicities associated with infusing donor CD8 cytotoxic T lymphocyte CTL clones specific for Wilms tumor WT1 in patients who have relapsed or at a high risk of relapse post transplant for myelodysplastic syndromes MDS chronic myelogenous leukemia CML acute myeloid leukemia AML or acute lymphoblastic leukemia ALL
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 WT1-specific T cells mediate antileukemic activity
OUTLINE Donors undergo leukapheresis for stem cell harvest to generate CD8-positive WT1 gene-specific CTL clones at the time of allogeneic stem cell transplantation
After post-transplantation hematopoietic recovery patients receive treatment for either highest-risk disease prophylactically or relapsed disease
Highest-risk disease group Patients receive CD8-positive WT1 gene-specific CTL clones intravenously IV over 1-2 hours on days 0 14 and 28 Beginning 2-4 hours after CTL infusion patients receive interleukin-2 subcutaneously SC twice daily on days 28-42 in the absence of unacceptable toxicity
Relapsed-disease group Some patients with evidence of leukemic relapse may receive standard salvage chemotherapy prior to donor CTL infusions and then receive CD8-positive WT1 gene-specific CTL clones and interleukin-2 as in the highest-risk group
Patients in both groups who have progressive disease after complete or partial response to therapy may be eligible for retreatment with CD8-positive WT1 gene-specific CTL clones
After completion of study treatment patients are followed every 3 months for 2 years
I To determine the safety and potential toxicities associated with infusing donor CD8 cytotoxic T lymphocyte CTL clones specific for Wilms tumor WT1 in patients who have relapsed or at a high risk of relapse post transplant for myelodysplastic syndromes MDS chronic myelogenous leukemia CML acute myeloid leukemia AML or acute lymphoblastic leukemia ALL
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 WT1-specific T cells mediate antileukemic activity
OUTLINE Donors undergo leukapheresis for stem cell harvest to generate CD8-positive WT1 gene-specific CTL clones at the time of allogeneic stem cell transplantation
After post-transplantation hematopoietic recovery patients receive treatment for either highest-risk disease prophylactically or relapsed disease
Highest-risk disease group Patients receive CD8-positive WT1 gene-specific CTL clones intravenously IV over 1-2 hours on days 0 14 and 28 Beginning 2-4 hours after CTL infusion patients receive interleukin-2 subcutaneously SC twice daily on days 28-42 in the absence of unacceptable toxicity
Relapsed-disease group Some patients with evidence of leukemic relapse may receive standard salvage chemotherapy prior to donor CTL infusions and then receive CD8-positive WT1 gene-specific CTL clones and interleukin-2 as in the highest-risk group
Patients in both groups who have progressive disease after complete or partial response to therapy may be eligible for retreatment with CD8-positive WT1 gene-specific CTL clones
After completion of study treatment patients are followed every 3 months for 2 years
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-2009-01471 | REGISTRY | None | None |