Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112593
Status:
COMPLETED
Last Update Posted:
2017-05-24
First Post:
2005-06-02
Brief Title:
Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Allogeneic Hematopoietic Stem Cell Transplantation for Induction of Mixed Hematopoietic Chimerism in Patients Infected With Human Immunodeficiency Virus-1 Using a Non-Marrow Ablative Conditioning Regimen Containing Total Body Irradiation in Combination With Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil
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 clinical trial studies the side effects and best dose of giving fludarabine and total-body irradiation TBI together followed by a donor stem cell transplant and cyclosporine and mycophenolate mofetil in treating human immunodeficiency virus HIV-positive patients with or without cancer Giving low doses of chemotherapy such as fludarabine and TBI before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune 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 cyclosporine CSP and mycophenolate mofetil MMF after the transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I To determine the safety of treating high-risk HIV1-infected patients with 200 centigray cGy TBI plus post-transplant MMFCSP
II To determine whether 200 cGy TBI plus post-transplant MMFCSP results in stable mixed donor lymphocyte chimerism 5-95 donor cluster of differentiation CD3 in high-risk human immunodeficiency virus HIV-1 infected patients
SECONDARY OBJECTIVES
I To define the kinetics of immune reconstitution following a non-lethal conditioning regimen in HIV1-infected patients
II To determine the effect of a non-lethal conditioning regimen on viral load
OUTLINE
CONDITIONING REGIMEN Patients receive fludarabine intravenously IV over 2 hours on days -4 -3 and -2 Patients undergo TBI on day 0
TRANSPLANTATION After completion of TBI patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine IV or orally PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of graft-vs-host disease GVHD Beginning within 6 hours after transplantation patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD
After completion of study treatment patients are followed up for at least 1 year
I To determine the safety of treating high-risk HIV1-infected patients with 200 centigray cGy TBI plus post-transplant MMFCSP
II To determine whether 200 cGy TBI plus post-transplant MMFCSP results in stable mixed donor lymphocyte chimerism 5-95 donor cluster of differentiation CD3 in high-risk human immunodeficiency virus HIV-1 infected patients
SECONDARY OBJECTIVES
I To define the kinetics of immune reconstitution following a non-lethal conditioning regimen in HIV1-infected patients
II To determine the effect of a non-lethal conditioning regimen on viral load
OUTLINE
CONDITIONING REGIMEN Patients receive fludarabine intravenously IV over 2 hours on days -4 -3 and -2 Patients undergo TBI on day 0
TRANSPLANTATION After completion of TBI patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine IV or orally PO 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of graft-vs-host disease GVHD Beginning within 6 hours after transplantation patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD
After completion of study treatment patients are followed up for at least 1 year
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-2010-00802 | REGISTRY | None | None |
| 141000 | OTHER | None | None |
| P30CA015704 | NIH | None | None |
| P01CA018029 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP01CA018029 |