Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278213
Status:
COMPLETED
Last Update Posted:
2018-05-11
First Post:
2006-01-16
Brief Title:
Combination Chemotherapy Followed By Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia
Sponsor:
German CLL Study Group
Organization:
German CLL Study Group
Study Overview
Official Title:
Consolidation With Campath-1H After FMC Induction in Patients With T-cell Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2018-05
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:
RATIONALE Drugs used in chemotherapy such as fludarabine cyclophosphamide and mitoxantrone work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more cancer cells Monoclonal antibodies such as alemtuzumab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others can find cancer cells and help kill them or carry cancer-killing substances to them Combination chemotherapy followed by alemtuzumab may be effective in treating chronic lymphocytic leukemia and prolymphocytic leukemia
PURPOSE This phase II trial is studying how well giving combination chemotherapy followed by alemtuzumab works in treating patients with T-cell chronic lymphocytic leukemia or prolymphocytic leukemia
PURPOSE This phase II trial is studying how well giving combination chemotherapy followed by alemtuzumab works in treating patients with T-cell chronic lymphocytic leukemia or prolymphocytic leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the number of severe adverse events and life-threatening infections in patients with T-cell chronic lymphocytic leukemia or T-cell prolymphocytic leukemia treated with induction chemotherapy comprising fludarabine cyclophosphamide and mitoxantrone hydrochloride followed by consolidation therapy comprising alemtuzumab
Determine the remission rate in patients treated with this regimen
Secondary
Determine the overall and progression-free survival of patients treated with this regimen
Determine the quality of remission in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive induction chemotherapy comprising fludarabine IV and cyclophosphamide IV for 3 days and mitoxantrone hydrochloride IV on 1 day Treatment repeats every 28 days for up to 4 courses Patients then receive consolidation therapy comprising alemtuzumab IV 3 times in week 1 and then weekly for up to 11 weeks
PROJECTED ACCRUAL A total of 17 patients will be accrued for this study
Primary
Determine the number of severe adverse events and life-threatening infections in patients with T-cell chronic lymphocytic leukemia or T-cell prolymphocytic leukemia treated with induction chemotherapy comprising fludarabine cyclophosphamide and mitoxantrone hydrochloride followed by consolidation therapy comprising alemtuzumab
Determine the remission rate in patients treated with this regimen
Secondary
Determine the overall and progression-free survival of patients treated with this regimen
Determine the quality of remission in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive induction chemotherapy comprising fludarabine IV and cyclophosphamide IV for 3 days and mitoxantrone hydrochloride IV on 1 day Treatment repeats every 28 days for up to 4 courses Patients then receive consolidation therapy comprising alemtuzumab IV 3 times in week 1 and then weekly for up to 11 weeks
PROJECTED ACCRUAL A total of 17 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 |
|---|---|---|---|
| EU-20562 | None | None | None |