Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002673
Status:
COMPLETED
Last Update Posted:
2010-06-17
First Post:
1999-11-01
Brief Title:
Immunotherapy in Treating Patients Who Are Undergoing Bone Marrow or Peripheral Stem Cell Transplantation
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A PHASE II STUDY OF CELLULAR ADOPTIVE IMMUNOTHERAPY AS PROPHYLAXIS FOR CYTOMEGALOVIRUS DISEASE AFTER ALLOGENEIC BONE MARROW TRANSPLANTATION
Status:
COMPLETED
Status Verified Date:
2010-06
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 White blood cells from donors who have been exposed to cytomegalovirus may be able to help prevent this infection from occurring in patients who are undergoing bone marrow or peripheral stem cell transplantation
PURPOSE Phase II trial to study the effectiveness of donated white blood cells to prevent cytomegalovirus infection in patients who are undergoing bone marrow or peripheral stem cell transplantation
PURPOSE Phase II trial to study the effectiveness of donated white blood cells to prevent cytomegalovirus infection in patients who are undergoing bone marrow or peripheral stem cell transplantation
Detailed Description:
OBJECTIVES I Determine whether adoptive immunotherapy comprising donor-derived CD8 CMV-specific major histocompatibility complex class I-restricted cytotoxic T-lymphocyte CTL clones CD8 CMV-specific CTL clones and CD4 CMV-specific T-helper Th-cell clones is effective in preventing CMV viremia and disease in CMV-positive patients with malignancies requiring allogeneic bone marrow or peripheral blood stem cell transplantation II Determine whether the transfer of CD4 CMV-specific Th-cell clones to patients with deficient responses can reconstitute CD4 Th-cell activity and augment adoptively transferred CD8 CMV-specific CTL clones
OUTLINE Allogeneic CD8 CMV-specific major histocompatibility complex class I-restricted cytotoxic T-lymphocyte CTL clones CD8 CMV-specific CTL clones and CD4 CMV-specific T-helper Th-cell clones are harvested and cultured in vitro at least 2 weeks before bone marrow or peripheral blood stem cell PBSC transplantation Bone marrow or PBSC are infused on day 0 Patients receive the first infusion of CD8 CMV-specific CTL clones beginning between days 28 and 45 posttransplantation followed 8 days later by the second infusion followed 2 days later by the first infusion of CD4 CMV-specific Th-cell clones Patients who receive prednisone posttransplantation or have deficient CD8 CTL responses ie less than 50 of the response measured in the immunocompetent bone marrow donor after the second infusion of CD8 CMV-specific CTL clones receive a third infusion of CD8 CMV-specific CTL clones and a second infusion of CD4 CMV-specific Th-cell clones before day 67
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 12-18 months
OUTLINE Allogeneic CD8 CMV-specific major histocompatibility complex class I-restricted cytotoxic T-lymphocyte CTL clones CD8 CMV-specific CTL clones and CD4 CMV-specific T-helper Th-cell clones are harvested and cultured in vitro at least 2 weeks before bone marrow or peripheral blood stem cell PBSC transplantation Bone marrow or PBSC are infused on day 0 Patients receive the first infusion of CD8 CMV-specific CTL clones beginning between days 28 and 45 posttransplantation followed 8 days later by the second infusion followed 2 days later by the first infusion of CD4 CMV-specific Th-cell clones Patients who receive prednisone posttransplantation or have deficient CD8 CTL responses ie less than 50 of the response measured in the immunocompetent bone marrow donor after the second infusion of CD8 CMV-specific CTL clones receive a third infusion of CD8 CMV-specific CTL clones and a second infusion of CD4 CMV-specific Th-cell clones before day 67
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 12-18 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 |
|---|---|---|---|
| CDR0000064307 | REGISTRY | PDQ | None |
| FHCRC-101101 | None | None | None |
| NCI-V95-0702 | None | None | None |