Ignite Creation Date:
2024-05-06 @ 12:45 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01640301
Status:
TERMINATED
Last Update Posted:
2022-07-14
First Post:
2011-11-29
Brief Title:
Laboratory-Treated T Cells in Treating Patients With High-Risk Relapsed Acute Myeloid Leukemia Myelodysplastic Syndrome or Chronic Myelogenous Leukemia Previously Treated With Donor Stem Cell Transplant
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Phase III Study of Adoptive Immunotherapy After Allogeneic HCT With Virus Specific CD8 T Cells That Have Been Transduced to Express a WT1-Specific T Cell Receptor for Patients With Relapsed AML
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to slow accrual
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 laboratory-treated T cells and to see how well they work in treating patients with high-risk acute myeloid leukemia AML myelodysplastic syndrome MDS or chronic myelogenous leukemia CML that has returned after a period of improvement relapsed previously treated with donor stem cell transplant Biological therapies such as cellular adoptive immunotherapy may stimulate the immune system in different ways and stop cancer cells from growing Placing a gene that has been created in the laboratory into a persons T cells may make the body build an immune response to kill cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the safety and potential toxicities associated with treating patients with high risk or relapsed AML MDS and CML after allogeneic hematopoietic cell transplantation HCT by adoptive transfer of virus-specific cluster of differentiation CD8 T cells genetically-modified to express a high affinity Wilms tumor 1 WT1-specific T cell receptor TCR
II Determine the anti-leukemic activity associated with treating patients with relapsed AML MDS and CML after allogeneic HCT by adoptive transfer of virus-specific CD8 T cells genetically-modified to express a high affinity WT1-specific T cell receptor TCR
SECONDARY OBJECTIVES
I Determine the in vivo persistence of transferred T cells and ability to migrate to and accumulate in bone marrow
II Determine the maintenance of TCR expression and function of transduced T cells
OUTLINE Patients are assigned to 1 of 2 treatment arms
ARM I Patients with no evidence of leukemia post-HCT receive WT1-sensitized T cells intravenously IV over 45 minutes or longer for patients who are 15-30 kg on days 0 and 14 and aldesleukin subcutaneously SC twice daily BID on days 14-28
ARM II Patients with evidence of AML minimal residual disease or overt relapse post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2 Patients also receive WT1-sensitized T cells IV over 45 minutes or longer for patients who are 15-30 kg on days 0 and 21 and aldesleukin SC BID on days 14-28
After completion of study treatment patients are followed up weekly for 4 weeks at weeks 6 and 8 at 3 6 12 months and then annually for up to 15 years
I Determine the safety and potential toxicities associated with treating patients with high risk or relapsed AML MDS and CML after allogeneic hematopoietic cell transplantation HCT by adoptive transfer of virus-specific cluster of differentiation CD8 T cells genetically-modified to express a high affinity Wilms tumor 1 WT1-specific T cell receptor TCR
II Determine the anti-leukemic activity associated with treating patients with relapsed AML MDS and CML after allogeneic HCT by adoptive transfer of virus-specific CD8 T cells genetically-modified to express a high affinity WT1-specific T cell receptor TCR
SECONDARY OBJECTIVES
I Determine the in vivo persistence of transferred T cells and ability to migrate to and accumulate in bone marrow
II Determine the maintenance of TCR expression and function of transduced T cells
OUTLINE Patients are assigned to 1 of 2 treatment arms
ARM I Patients with no evidence of leukemia post-HCT receive WT1-sensitized T cells intravenously IV over 45 minutes or longer for patients who are 15-30 kg on days 0 and 14 and aldesleukin subcutaneously SC twice daily BID on days 14-28
ARM II Patients with evidence of AML minimal residual disease or overt relapse post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2 Patients also receive WT1-sensitized T cells IV over 45 minutes or longer for patients who are 15-30 kg on days 0 and 21 and aldesleukin SC BID on days 14-28
After completion of study treatment patients are followed up weekly for 4 weeks at weeks 6 and 8 at 3 6 12 months and then annually for up to 15 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NCI-2011-03362 | REGISTRY | None | None |
| 2498 | None | None | None |
| 249800 | OTHER | None | None |
| P01CA018029 | NIH | None | None |
| RG9212029 | OTHER | Fred HutchUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP01CA018029 |