Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006390
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2000-10-04
Brief Title:
Alemtuzumab Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Study of Campath-1H NSC 950010 and Peripheral Blood Stem Cell Transplant for Patients With Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2023-06
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 alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy Combining monoclonal antibody therapy chemotherapy radiation therapy and peripheral stem cell transplantation may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of alemtuzumab plus peripheral stem cell transplantation in treating patients who have chronic lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of alemtuzumab plus peripheral stem cell transplantation in treating patients who have chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Determine the ability of in vivo purging with alemtuzumab monoclonal antibody CD52 Campath-1H to produce a stem cell graft without detectable leukemia cells in patients with chronic lymphocytic leukemia
Determine the ability to successfully mobilize stem cells after in vivo purging with monoclonal antibody CD52 in these patients
Determine the toxicity of this treatment regimen in these patients
Determine the response to this treatment regimen in these patients at 6 months after peripheral blood stem cell transplantation
OUTLINE This is a multicenter study
Patients receive induction therapy comprising alemtuzumab monoclonal antibody CD52 Campath-1H IV over 2 hours three times a week for 4 weeks
Beginning no more than 2 weeks after induction therapy patients receive mobilization chemotherapy comprising cyclophosphamide IV over 1-2 hours on day 1 and filgrastim G-CSF subcutaneously SC starting on day 2 and continuing until the last day of apheresis Patients undergo peripheral blood stem cell apheresis on days 10-14
Beginning 2-4 weeks after apheresis patients receive a preparative regimen comprising cyclophosphamide IV over 2 hours on days -5 and -4 and fractionated total body irradiation twice a day over 6-10 hours on days -3 to -1 Patients undergo peripheral blood stem cell transplantation on day 0 Patients receive G-CSF SC beginning on day 1 and continuing until blood counts recover
Patients are followed at 60 days 1 year and then annually thereafter until disease progression
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Determine the ability of in vivo purging with alemtuzumab monoclonal antibody CD52 Campath-1H to produce a stem cell graft without detectable leukemia cells in patients with chronic lymphocytic leukemia
Determine the ability to successfully mobilize stem cells after in vivo purging with monoclonal antibody CD52 in these patients
Determine the toxicity of this treatment regimen in these patients
Determine the response to this treatment regimen in these patients at 6 months after peripheral blood stem cell transplantation
OUTLINE This is a multicenter study
Patients receive induction therapy comprising alemtuzumab monoclonal antibody CD52 Campath-1H IV over 2 hours three times a week for 4 weeks
Beginning no more than 2 weeks after induction therapy patients receive mobilization chemotherapy comprising cyclophosphamide IV over 1-2 hours on day 1 and filgrastim G-CSF subcutaneously SC starting on day 2 and continuing until the last day of apheresis Patients undergo peripheral blood stem cell apheresis on days 10-14
Beginning 2-4 weeks after apheresis patients receive a preparative regimen comprising cyclophosphamide IV over 2 hours on days -5 and -4 and fractionated total body irradiation twice a day over 6-10 hours on days -3 to -1 Patients undergo peripheral blood stem cell transplantation on day 0 Patients receive G-CSF SC beginning on day 1 and continuing until blood counts recover
Patients are followed at 60 days 1 year and then annually thereafter until disease progression
PROJECTED ACCRUAL A total of 30 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 |
|---|---|---|---|
| ECOG-8998 | None | None | None |