Ignite Creation Date:
2024-05-05 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00521261
Status:
WITHDRAWN
Last Update Posted:
2014-03-05
First Post:
2007-08-24
Brief Title:
Donor T Cells Low-Dose Aldesleukin and Low-Dose GM-CSF After Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Immune Consolidation With Allogeneic Activated T Cells Armed With OKT3 x Rituxan Anti-CD3 x Anti-CD20 Bispecific Antibody CD20Bi After Allogeneic Peripheral Blood Stem Cell Transplant for High Risk CD20 Non-Hodgkins Lymphoma Phase I
Status:
WITHDRAWN
Status Verified Date:
2014-03
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:
RATIONALE Giving high doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells It also stops the patients immune system from rejecting the donors stem cells Colony stimulating factors such as aldesleukin and GM-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy The donated stem cells may replace the patients immune cells and help destroy any remaining cancer cells graft-versus-tumor effect Giving an infusion of the donors T cells that have been treated with antibodies after the transplant may help increase this effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving tacrolimus and mycophenolate mofetil after transplant may stop this from happening
PURPOSE This phase I trial is studying the side effects and best dose of donor T cells given together with low-dose aldesleukin and low-dose GM-CSF after donor stem cell transplant in treating patients with relapsed or refractory non-Hodgkins lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of donor T cells given together with low-dose aldesleukin and low-dose GM-CSF after donor stem cell transplant in treating patients with relapsed or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of donor-derived allogeneic anti-CD3 X anti-CD20 bispecific antibody CD20Bi-armed activated T cells ATC when given with low-dose aldesleukin and low-dose sargramostim GM-CSF after allogeneic stem cell transplantation in patients with relapsed or refractory CD20-positive non-Hodgkin lymphoma
Perform trafficking studies using indium I 111-labeled unarmed ATC and ATC armed with CD20Bi in patients with evaluable lymphoma sites to determine whether armed ATC specifically traffic to tumor sites and correlate these data with CT and PET scans
Evaluate immune responses and immune reconstitution of T and B cells
OUTLINE All patients receive high-dose chemotherapy that is standard of care for their disease Peripheral blood lymphocytes are obtained from the HLA-identical sibling donor and cultured to obtain activated T cells ATC some of which are subsequently armed with CD20 bispecific antibody CD20Bi and cryopreserved for later use Patients then undergo allogeneic hematopoietic stem cell transplantation SCT
Patients receive ATC-CD20Bi IV on days 40 70 100 130 and 160 after SCT Patients receive low-dose aldesleukin subcutaneously SC once daily for 7 days beginning within 24 hours after each ATC-CD20Bi infusion and low-dose sargramostim GM-CSF SC every other day for 3 doses beginning within 24 hours after each infusion of ATC-CD20Bi Patients also receive tacrolimus and mycophenolate mofetil as standard graft-vs-host disease prophylaxis Treatment continues in the absence of unacceptable toxicity
Some patients with well-defined or evaluable masses receive indium I 111 111I-labeled ATC-CD20Bi IV and 111I-labeled unarmed ATC and then undergo whole-body imaging for trafficking studies
After completion of study treatment patients are followed at 6 months 12 months and then annually thereafter
Determine the maximum tolerated dose of donor-derived allogeneic anti-CD3 X anti-CD20 bispecific antibody CD20Bi-armed activated T cells ATC when given with low-dose aldesleukin and low-dose sargramostim GM-CSF after allogeneic stem cell transplantation in patients with relapsed or refractory CD20-positive non-Hodgkin lymphoma
Perform trafficking studies using indium I 111-labeled unarmed ATC and ATC armed with CD20Bi in patients with evaluable lymphoma sites to determine whether armed ATC specifically traffic to tumor sites and correlate these data with CT and PET scans
Evaluate immune responses and immune reconstitution of T and B cells
OUTLINE All patients receive high-dose chemotherapy that is standard of care for their disease Peripheral blood lymphocytes are obtained from the HLA-identical sibling donor and cultured to obtain activated T cells ATC some of which are subsequently armed with CD20 bispecific antibody CD20Bi and cryopreserved for later use Patients then undergo allogeneic hematopoietic stem cell transplantation SCT
Patients receive ATC-CD20Bi IV on days 40 70 100 130 and 160 after SCT Patients receive low-dose aldesleukin subcutaneously SC once daily for 7 days beginning within 24 hours after each ATC-CD20Bi infusion and low-dose sargramostim GM-CSF SC every other day for 3 doses beginning within 24 hours after each infusion of ATC-CD20Bi Patients also receive tacrolimus and mycophenolate mofetil as standard graft-vs-host disease prophylaxis Treatment continues in the absence of unacceptable toxicity
Some patients with well-defined or evaluable masses receive indium I 111 111I-labeled ATC-CD20Bi IV and 111I-labeled unarmed ATC and then undergo whole-body imaging for trafficking studies
After completion of study treatment patients are followed at 6 months 12 months and then annually thereafter
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 |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| WSU-2007-034 | None | None | None |
| 2365-118650022302 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |