Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262782
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2005-12-06
Brief Title:
Fludarabine or Observation in Treating Patients With Stage 0 Stage I or Stage II Chronic Lymphocytic Leukemia
Sponsor:
German CLL Study Group
Organization:
German CLL Study Group
Study Overview
Official Title:
Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2020-02
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 work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Sometimes the cancer may not need treatment until it progresses In this case observation may be sufficient It is not yet known whether fludarabine is more effective than observation in treating chronic lymphocytic leukemia
PURPOSE This randomized phase III trial is studying fludarabine to see how well it works compared to observation only in treating patients with stage 0 stage I or stage II B-cell chronic lymphocytic leukemia
PURPOSE This randomized phase III trial is studying fludarabine to see how well it works compared to observation only in treating patients with stage 0 stage I or stage II B-cell chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Identify prognostic factors that predict a short survival in patients with stage 0-II B-cell chronic lymphocytic leukemia treated with fludarabine or observation only
OUTLINE This is a randomized study Patients are stratified according to risk high risk vs low risk Patients in the low-risk group undergo observation only Patients in the high-risk group are randomized to 1 of 2 treatment arms
Arm I Patients receive fludarabine
Arm II Patients undergo observation only
PROJECTED ACCRUAL A total of 880 patients will be accrued for this study
Identify prognostic factors that predict a short survival in patients with stage 0-II B-cell chronic lymphocytic leukemia treated with fludarabine or observation only
OUTLINE This is a randomized study Patients are stratified according to risk high risk vs low risk Patients in the low-risk group undergo observation only Patients in the high-risk group are randomized to 1 of 2 treatment arms
Arm I Patients receive fludarabine
Arm II Patients undergo observation only
PROJECTED ACCRUAL A total of 880 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 |
|---|---|---|---|
| MEDAC-GCLLSG-CLL1 | None | None | None |
| EU-20548 | None | None | None |
| GCLLSG-138 | None | None | None |