Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330252
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2006-05-25
Brief Title:
Weekly Subcutaneous Alemtuzumab and Rituximab for Relapsed CLL
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Weekly Subcutaneous Alemtuzumab and Rituximab for Relapsed CLL
Status:
COMPLETED
Status Verified Date:
2016-05
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:
The purpose of this study is to determine whether the combination of alemtuzumab and rituximab is safe and effective in treating patients with relapsed Chronic Lymphocytic Leukemia CLL and to determine whether alemtuzumab can be given as a single weekly subcutaneous dose together with rituximab
Detailed Description:
This study proposes to combine alemtuzumab which effectively treats peripheral blood and bone marrow disease in CLL with rituximab which has activity in lymph node disease in a streamlined and convenient administration schedule Preclinical data support synergistic interaction of the two The primary objectives are 1 to determine the overall and complete response CR rate in patients with relapsed CLL and to determine the safety of the combination and 2 the safety of higher doses of alemtuzumab at less frequent intervals Secondary objectives are 1 to describe the duration of response progression-free survival and overall survival in patients not proceeding to allo transplant 2 to determine the improvement in overall and complete response associated with administration of a 2nd eight week course of therapy and 3 to assess minimal residual disease in certain patients and to correlate those results with survival If at least 16 responses are observed among 35 patients then the treatment will be considered promising
The development of antibody therapies has held promise for CLL since CLL therapies have been palliative with no established therapy shown to improve survival Studies have suggested that in contrast to what is seen with fludarabine and alkylating agents response rates to alemtuzumab are maintained in CLL subjects with P53 mutations Tolerability of rituximab and its major activity in nodes make it an attractive candidate for combination with alemtuzumab
This is a single center DFHCC single arm multi cohort phase I study with treatment on an outpatient basis If the initial alemtuzumab dose of 30 mg sc d1 3and 5 is tolerated there will be dose escalations in cohorts of 3 up to 90 mg d1 per week Following determination of a maximum tolerated dose accrual of all remaining patients will occur at that dose Subjects will be restaged after 8 weeks of therapy and may proceed to transplant If deriving benefit but not in CR subjects may receive another 8 weeks of therapy
The development of antibody therapies has held promise for CLL since CLL therapies have been palliative with no established therapy shown to improve survival Studies have suggested that in contrast to what is seen with fludarabine and alkylating agents response rates to alemtuzumab are maintained in CLL subjects with P53 mutations Tolerability of rituximab and its major activity in nodes make it an attractive candidate for combination with alemtuzumab
This is a single center DFHCC single arm multi cohort phase I study with treatment on an outpatient basis If the initial alemtuzumab dose of 30 mg sc d1 3and 5 is tolerated there will be dose escalations in cohorts of 3 up to 90 mg d1 per week Following determination of a maximum tolerated dose accrual of all remaining patients will occur at that dose Subjects will be restaged after 8 weeks of therapy and may proceed to transplant If deriving benefit but not in CR subjects may receive another 8 weeks of therapy
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