Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017108
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2001-06-06
Brief Title:
Chlorambucil in Treating Patients With Advanced Chronic Lymphocytic Leukemia
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Low Dose Chlorambucil Maintenance Vs No Treatment Following High-Dose Chlorambucil Induction In Patients With Advanced B-Chronic Lymphocytic Leukemia A Randomized Phase III Study Of The EORTC LG CLL-3
Status:
UNKNOWN
Status Verified Date:
2004-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 use different ways to stop cancer cells from dividing so they stop growing or die It is not yet known which chlorambucil regimen is more effective in treating advanced chronic lymphocytic leukemia
PURPOSE Randomized phase III trial to determine the effectiveness of different regimens of chlorambucil in treating patients who have advanced chronic lymphocytic leukemia
PURPOSE Randomized phase III trial to determine the effectiveness of different regimens of chlorambucil in treating patients who have advanced chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Compare overall and disease-related survival of patients with B-cell chronic lymphocytic leukemia treated with high-dose chlorambucil induction therapy with or without low-dose chlorambucil maintenance therapy
Compare the time to salvage treatment in these patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare the treatment-related mortality of these patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center time to complete response before 12 weeks vs after 12 weeks vs partial response and cytopenia at diagnosis Binet stage AB vs C
All patients receive induction therapy comprising high-dose oral chlorambucil daily Treatment continues until achievement of complete response or a maximum of 24 weeks in the absence of disease progression or unacceptable toxicity
Patients who respond to induction therapy are randomized to 1 of 2 treatment arms for maintenance therapy
Arm I Patients receive low-dose oral chlorambucil twice a week Therapy continues for up to 5 years in the absence of disease progression or unacceptable toxicity If disease progression occurs then patients may proceed to salvage therapy
Arm II Patients receive no maintenance therapy If disease progresses patients receive induction therapy again If disease does not respond to re-induction therapy then patients may proceed to salvage therapy
Salvage therapy Patients with progressive disease during maintenance therapy receive fludarabine IV daily and cyclophosphamide IV daily on days 1-3 Treatment repeats every 4 weeks for 3-6 courses
Patients are followed monthly for 3 months every 2 months for 6 months and then every 3 months thereafter
PROJECTED ACCRUAL Approximately 470 patients will be accrued for this study within 47 years
Compare overall and disease-related survival of patients with B-cell chronic lymphocytic leukemia treated with high-dose chlorambucil induction therapy with or without low-dose chlorambucil maintenance therapy
Compare the time to salvage treatment in these patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare the treatment-related mortality of these patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center time to complete response before 12 weeks vs after 12 weeks vs partial response and cytopenia at diagnosis Binet stage AB vs C
All patients receive induction therapy comprising high-dose oral chlorambucil daily Treatment continues until achievement of complete response or a maximum of 24 weeks in the absence of disease progression or unacceptable toxicity
Patients who respond to induction therapy are randomized to 1 of 2 treatment arms for maintenance therapy
Arm I Patients receive low-dose oral chlorambucil twice a week Therapy continues for up to 5 years in the absence of disease progression or unacceptable toxicity If disease progression occurs then patients may proceed to salvage therapy
Arm II Patients receive no maintenance therapy If disease progresses patients receive induction therapy again If disease does not respond to re-induction therapy then patients may proceed to salvage therapy
Salvage therapy Patients with progressive disease during maintenance therapy receive fludarabine IV daily and cyclophosphamide IV daily on days 1-3 Treatment repeats every 4 weeks for 3-6 courses
Patients are followed monthly for 3 months every 2 months for 6 months and then every 3 months thereafter
PROJECTED ACCRUAL Approximately 470 patients will be accrued for this study within 47 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-06992-CLL-3 | None | None | None |