Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040846
Status:
COMPLETED
Last Update Posted:
2020-01-29
First Post:
2002-07-08
Brief Title:
Alemtuzumab Fludarabine Phosphate and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies
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 I Mismatched Donor Stem Cell Transplantation for Patients With Hematologic Malignancies - A Multi-Center Trial
Status:
COMPLETED
Status Verified Date:
2020-01
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 the side effects and the best dose of alemtuzumab when given together with fludarabine phosphate and low-dose total body irradiation TBI and how well it works before donor stem cell transplant in treating patients with hematological malignancies Giving chemotherapy and low-dose TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells It may also stop the patients immune system from rejecting the donors stem cells Also monoclonal antibodies such as alemtuzumab can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells When the healthy stem cells from a donor are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets 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 transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I To determine whether stable allogeneic engraftment from related and unrelated human leukocyte antigen HLA-mismatched stem cell donors can be safely established using a non-myeloablative conditioning regimen plus escalating doses of the anti-CD52 monoclonal antibody mAb Campath alemtuzumab in patients with hematologic malignancies
SECONDARY OBJECTIVES
I Evaluate the risk of occurrence of acute and chronic graft-vs-host disease GVHD
II Evaluate the riskincidence of infections
III Determine whether engraftment can be maintained with a single dose fludarabine donor lymphocyte infusion DLI and continued MMFCSP
IV Evaluate the risk for disease progression and relapse
OUTLINE This is a dose-escalation study of alemtuzumab
CONDITIONING REGIMEN Patients receive alemtuzumab intravenously IV over 2 hours on days -8 to -5 and fludarabine phosphate IV on days -4 to -2 Patients also undergo low-dose TBI on day 0
HEMATOPOIETIC STEM CELL TRANSPLANTATION HSCT Patients undergo allogeneic peripheral blood stem cell transplantation on day 0
IMMUNOSUPPRESSION Patients receive CSP IV or orally PO twice daily BID on days -3 to 180 with taper to day 365 and MMF PO thrice daily TID on days 0-100 with taper to day 156
After completion of study treatment patients are followed up periodically
I To determine whether stable allogeneic engraftment from related and unrelated human leukocyte antigen HLA-mismatched stem cell donors can be safely established using a non-myeloablative conditioning regimen plus escalating doses of the anti-CD52 monoclonal antibody mAb Campath alemtuzumab in patients with hematologic malignancies
SECONDARY OBJECTIVES
I Evaluate the risk of occurrence of acute and chronic graft-vs-host disease GVHD
II Evaluate the riskincidence of infections
III Determine whether engraftment can be maintained with a single dose fludarabine donor lymphocyte infusion DLI and continued MMFCSP
IV Evaluate the risk for disease progression and relapse
OUTLINE This is a dose-escalation study of alemtuzumab
CONDITIONING REGIMEN Patients receive alemtuzumab intravenously IV over 2 hours on days -8 to -5 and fludarabine phosphate IV on days -4 to -2 Patients also undergo low-dose TBI on day 0
HEMATOPOIETIC STEM CELL TRANSPLANTATION HSCT Patients undergo allogeneic peripheral blood stem cell transplantation on day 0
IMMUNOSUPPRESSION Patients receive CSP IV or orally PO twice daily BID on days -3 to 180 with taper to day 365 and MMF PO thrice daily TID on days 0-100 with taper to day 156
After completion of study treatment patients are followed up periodically
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-2011-00471 | REGISTRY | None | None |
| 159100 | OTHER | None | None |
| P30CA015704 | NIH | None | None |
| P01CA018029 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP01CA018029 |