Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006350
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2000-10-04
Brief Title:
Mycophenolate Mofetil Tacrolimus Daclizumab and Donor Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Allogeneic Hematopoietic Stem Cell Transplantation for Hematologic Malignancies After a Non-Myeloablative Conditioning Regimen From HLA-Matched Sibling Donors
Status:
COMPLETED
Status Verified Date:
2019-10
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 Monoclonal antibodies such as daclizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Peripheral stem cell transplantation from a brother or sister may be effective treatment for hematologic cancer Sometimes the transplanted cells can be rejected by the bodys tissue Mycophenolate mofetil tacrolimus and donor white blood cells may prevent this from happening
PURPOSE Phase II trial to study the effectiveness of mycophenolate mofetil tacrolimus daclizumab and donor peripheral stem cell transplantation in treating patients who have hematologic cancer
PURPOSE Phase II trial to study the effectiveness of mycophenolate mofetil tacrolimus daclizumab and donor peripheral stem cell transplantation in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES I Determine whether donor hematopoiesis can be safely established using a nonmyeloablative conditioning regimen followed by HLA matched sibling donor peripheral blood stem cell transplantation in patients with hematologic malignancies II Determine whether mixed chimerism can be safely converted to full donor hematopoiesis with this treatment regimen in these patients III Determine the toxicity and incidence of aplasia and graft versus host disease in these patients treated with this regimen IV Determine the antitumor potential of this treatment regimen in these patients V Determine the role of NFkB in the modulation of the cytokine secretion profile of T lymphocytes during an alloimmune response in these patients treated with this regimen
OUTLINE Patients receive immunosuppressive medications consisting of oral mycophenolate mofetil and tacrolimus twice a day beginning on day -8 and continuing through day 45 in the absence of graft versus host disease Patients also receive daclizumab IV over 30 minutes on days -1 3 and 8 Patients undergo allogeneic peripheral blood stem cell PBSC transplantation with donor CD34 cells IV on day 0 If there is 0-80 donor hematopoiesis patients receive donor lymphocyte infusions with CD3 cells IV on days 75 165 and 270
PROJECTED ACCRUAL A total of 10-45 patients will be accrued for this study
OUTLINE Patients receive immunosuppressive medications consisting of oral mycophenolate mofetil and tacrolimus twice a day beginning on day -8 and continuing through day 45 in the absence of graft versus host disease Patients also receive daclizumab IV over 30 minutes on days -1 3 and 8 Patients undergo allogeneic peripheral blood stem cell PBSC transplantation with donor CD34 cells IV on day 0 If there is 0-80 donor hematopoiesis patients receive donor lymphocyte infusions with CD3 cells IV on days 75 165 and 270
PROJECTED ACCRUAL A total of 10-45 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-V00-1624 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068212 | REGISTRY | None | None |