Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004218
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2000-01-28
Brief Title:
Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
Sponsor:
Leukemia Research Fund
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Chronic Lymphocytic Leukemia Trial 4 A Randomized Comparison of Chlorambucil Fludarabine and Fludarabine Plus Cyclophosphamide
Status:
COMPLETED
Status Verified Date:
2006-01
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:
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 regimen of chemotherapy is more effective for chronic lymphocytic leukemia
PURPOSE This randomized phase III trial is studying chlorambucil to see how well it works compared to fludarabine and cyclophosphamide or fludarabine alone in treating patients with newly diagnosed chronic lymphocytic leukemia
PURPOSE This randomized phase III trial is studying chlorambucil to see how well it works compared to fludarabine and cyclophosphamide or fludarabine alone in treating patients with newly diagnosed chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Compare the survival rate of patients with newly diagnosed chronic lymphocytic leukemia treated with chlorambucil alone vs fludarabine with or without cyclophosphamide
Compare the response rate and duration of remission in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare the quality of life of patients treated with these regimens
Determine the impact of the drug response information provided by the DiSC assay on response rate and survival in relapsed or nonresponding patients
Assess the prognostic value of five genetic markers trisomy 12 and deletions at 11q23 13q14 p53 and 6q21 in patients treated with these regimens
OUTLINE This is a randomized study Patients enter one of three treatment arms in the first randomization Depending on response some patients may also participate in a second randomization to one of two treatment arms
First randomization
Arm I Patients receive oral chlorambucil daily for 7 days Treatment repeats every 4 weeks until maximum response or up to 1 year
Arm II Patients receive fludarabine IV or orally daily for 5 days Treatment repeats every 4 weeks for 3-8 courses
Arm III Patients receive cyclophosphamide IV and fludarabine IV for 3 days or orally daily for 5 days Treatment repeats every 4 weeks for 3-8 courses
Patients who relapse after being in remission for at least 1 year may repeat the initial therapy or may participate in a second randomization Patients who experience progressive disease or relapse within 1 year after treatment proceed to a second randomization
Second randomization
Arm I Treatment is guided by the results of the DiSC assay Treatment may be one of the first-line treatments with fludarabine or standard CHOP chemotherapy repeated every 4 weeks cyclophosphamide IV doxorubicin IV vincristine IV and oral prednisolone on days 1-5 or any other therapy guided by the results of the DiSC assay
Arm II Treatment is physicians choice which may include any of the options in arm I
Quality of life is assessed prior to initial therapy at 3 6 and 12 months and then annually thereafter
Patients are followed annually for survival
PROJECTED ACCRUAL A total of 750 patients will be accrued for this study within 6-7 years
Compare the survival rate of patients with newly diagnosed chronic lymphocytic leukemia treated with chlorambucil alone vs fludarabine with or without cyclophosphamide
Compare the response rate and duration of remission in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
Compare the quality of life of patients treated with these regimens
Determine the impact of the drug response information provided by the DiSC assay on response rate and survival in relapsed or nonresponding patients
Assess the prognostic value of five genetic markers trisomy 12 and deletions at 11q23 13q14 p53 and 6q21 in patients treated with these regimens
OUTLINE This is a randomized study Patients enter one of three treatment arms in the first randomization Depending on response some patients may also participate in a second randomization to one of two treatment arms
First randomization
Arm I Patients receive oral chlorambucil daily for 7 days Treatment repeats every 4 weeks until maximum response or up to 1 year
Arm II Patients receive fludarabine IV or orally daily for 5 days Treatment repeats every 4 weeks for 3-8 courses
Arm III Patients receive cyclophosphamide IV and fludarabine IV for 3 days or orally daily for 5 days Treatment repeats every 4 weeks for 3-8 courses
Patients who relapse after being in remission for at least 1 year may repeat the initial therapy or may participate in a second randomization Patients who experience progressive disease or relapse within 1 year after treatment proceed to a second randomization
Second randomization
Arm I Treatment is guided by the results of the DiSC assay Treatment may be one of the first-line treatments with fludarabine or standard CHOP chemotherapy repeated every 4 weeks cyclophosphamide IV doxorubicin IV vincristine IV and oral prednisolone on days 1-5 or any other therapy guided by the results of the DiSC assay
Arm II Treatment is physicians choice which may include any of the options in arm I
Quality of life is assessed prior to initial therapy at 3 6 and 12 months and then annually thereafter
Patients are followed annually for survival
PROJECTED ACCRUAL A total of 750 patients will be accrued for this study within 6-7 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 |
|---|---|---|---|
| ISRCTN58585610 | None | None | None |
| LRF-CLL4 | None | None | None |
| LRG-MRC-LEUK-CLL4 | None | None | None |
| EU-99030 | None | None | None |
| MRC-LEUK-CLL4 | None | None | None |
| EUDRACT-58585610 | None | None | None |