Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049504
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2002-11-12
Brief Title:
Haploidentical Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Nonmyeloablative Hematopoietic Stem Cell Transplantation for Patients With High-Risk Hematologic Malignancies Using Related HLA-Haploidentical Donors A Phase II Trial of Combined Immunosuppression Before and After Transplantation
Status:
COMPLETED
Status Verified Date:
2017-04
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 II trial studies how well giving fludarabine phosphate cyclophosphamide tacrolimus mycophenolate mofetil and total-body irradiation together with a donor bone marrow transplant works in treating patients with high-risk hematologic cancer Giving low doses of chemotherapy such as fludarabine phosphate and cyclophosphamide and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells by stopping them from dividing or killing them Giving cyclophosphamide after transplant may also stop the patients immune system from rejecting the donors bone marrow stem cells The donated stem cells may replace the patients immune system cells and help destroy any remaining cancer cells graft-versus-tumor 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 the transplant may stop this from happening
Detailed Description:
OBJECTIVES
I To determine if engraftment can be achieved safely in patients with high-risk hematologic malignancies who undergo non-myeloablative bone marrow transplantation BMT from human leukocyte antigen HLA-haploidentical donors
OUTLINE
NONMYELOABLATIVE CONDITIONING Patients receive fludarabine phosphate intravenously IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5 Patients undergo total body irradiation on day -1
TRANSPLANTATION Patients undergo BMT from an HLA-haploidentical donor on day 0
POST-TRANSPLANT IMMUNOSUPPRESSION Patients receive cyclophosphamide IV over 1 hour on day 3
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS Patients receive tacrolimus IV over 1-2 hours and then tacrolimus orally PO once tolerated on days 4-180 with taper on day 86 in the absence of graft-versus-host disease Patients also receive mycophenolate mofetil PO three times daily on days 4-35
Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 6 months and then annually thereafter
I To determine if engraftment can be achieved safely in patients with high-risk hematologic malignancies who undergo non-myeloablative bone marrow transplantation BMT from human leukocyte antigen HLA-haploidentical donors
OUTLINE
NONMYELOABLATIVE CONDITIONING Patients receive fludarabine phosphate intravenously IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5 Patients undergo total body irradiation on day -1
TRANSPLANTATION Patients undergo BMT from an HLA-haploidentical donor on day 0
POST-TRANSPLANT IMMUNOSUPPRESSION Patients receive cyclophosphamide IV over 1 hour on day 3
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS Patients receive tacrolimus IV over 1-2 hours and then tacrolimus orally PO once tolerated on days 4-180 with taper on day 86 in the absence of graft-versus-host disease Patients also receive mycophenolate mofetil PO three times daily on days 4-35
Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 6 months and then annually thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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-2010-00166 | REGISTRY | CTRP Clinical Trial Reporting Program | None |