Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
|ClinicalTrials.gov Identifier: NCT00262782|
Recruitment Status : Completed
First Posted : December 7, 2005
Last Update Posted : September 13, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Fludarabine||Phase 3|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||877 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia|
|Study Start Date :||April 1997|
|Primary Completion Date :||December 2004|
|Study Completion Date :||June 2010|
Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles
Other Name: Fludura
|No Intervention: watch & wait|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262782
Show 117 Study Locations
|Study Chair:||Michael Hallek, MD||Medizinische Universitaetsklinik I at the University of Cologne|