Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118352
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2005-07-08
Brief Title:
Alemtuzumab Fludarabine Phosphate and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Campath Alemtuzumab Dose Escalation Low-Dose TBI and Fludarabine Followed by HLA Class II Mismatched Donor Stem Cell Transplantation for Patients With Hematologic Malignancies A Multicenter Trial
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 is studying the side effects and best dose of alemtuzumab when given together with fludarabine phosphate and total-body irradiation followed by cyclosporine and mycophenolate mofetil in treating patients who are undergoing a donor stem cell transplant for hematologic cancer Giving low doses of chemotherapy such as fludarabine phosphate a monoclonal antibody such as alemtuzumab and radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells Giving chemotherapy or radiation therapy before or after transplant also stops the patients immune system from rejecting the donors bone marrow 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 and mycophenolate mofetil after the transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I To determine which dose of Campath alemtuzumab allows related and unrelated human leukocyte antigen HLA class-II mismatched hematopoietic cell transplantation HCT with an incidence of grade III-IV acute graft-versus-host disease GVHD less than 40
SECONDARY OBJECTIVES
I Incidence of graft rejection
II Number of days of steroids 1mgkg required before day 100 in each patient
III Incidence of non-relapse mortality
IV Riskincidence of infections
V Immune reconstitution
VI Risk for disease progression and relapse
OUTLINE This is a dose-escalation study of alemtuzumab
NONMYELOABLATIVE CONDITIONING REGIMEN Patients receive alemtuzumab intravenously IV over 6 hours once daily on days -6 -5 and -4 OR days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4 -3 and -2 Patients also undergo low-dose total-body irradiation TBI on day 0
ALLOGENEIC PERIPHERAL BLOOD STEM CELL TRANSPLANTATION PBSCT After completion of TBI patients undergo allogeneic PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO or IV every 12 hours on days -3 to 180 followed by a taper until day 365 in the absence of GVHD Beginning 4-6 hours after completion of allogeneic PBSCT patients receive mycophenolate mofetil PO every 8 hours on days 0 to 100 followed by a taper until day 156 in the absence of GVHD
After completion of study treatment patients are followed up periodically for 12 months at 18 months and then annually for 5 years
I To determine which dose of Campath alemtuzumab allows related and unrelated human leukocyte antigen HLA class-II mismatched hematopoietic cell transplantation HCT with an incidence of grade III-IV acute graft-versus-host disease GVHD less than 40
SECONDARY OBJECTIVES
I Incidence of graft rejection
II Number of days of steroids 1mgkg required before day 100 in each patient
III Incidence of non-relapse mortality
IV Riskincidence of infections
V Immune reconstitution
VI Risk for disease progression and relapse
OUTLINE This is a dose-escalation study of alemtuzumab
NONMYELOABLATIVE CONDITIONING REGIMEN Patients receive alemtuzumab intravenously IV over 6 hours once daily on days -6 -5 and -4 OR days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4 -3 and -2 Patients also undergo low-dose total-body irradiation TBI on day 0
ALLOGENEIC PERIPHERAL BLOOD STEM CELL TRANSPLANTATION PBSCT After completion of TBI patients undergo allogeneic PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO or IV every 12 hours on days -3 to 180 followed by a taper until day 365 in the absence of GVHD Beginning 4-6 hours after completion of allogeneic PBSCT patients receive mycophenolate mofetil PO every 8 hours on days 0 to 100 followed by a taper until day 156 in the absence of GVHD
After completion of study treatment patients are followed up periodically for 12 months at 18 months and then annually for 5 years
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-2009-01496 | REGISTRY | None | None |
| 195900 | OTHER | None | None |
| P01CA018029 | NIH | None | None |
| P30CA015704 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |