Early or Delayed Fludarabine and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia
Stopped early · Phase 3
Conditions studied: Leukemia
In brief
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. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fludarabine together with rituximab may kill more cancer cells. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving fludarabine together with rituximab early is more effective than giving fludarabine and rituximab after observation in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying fludarabine and rituximab to compare how well they work when given early or after observation in treating patients with previously untreated chronic lymphocytic leukemia.
Key facts
- Study ID
- NCT00513747
- Run by
- Alliance for Clinical Trials in Oncology
- People needed
- 84
- Starts
- 2008-01-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2020-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Clearview Cancer Institute — Huntsville, Alabama, United States
- Sparks Regional Medical Center — Fort Smith, Arkansas, United States
- Providence Saint Joseph Medical Center - Burbank — Burbank, California, United States
- Virginia K. Crosson Cancer Center at St. Jude Medical Center — Fullerton, California, United States
- Memorial Medical Center — Modesto, California, United States
- Camino Medical Group - Treatment Center — Mountain View, California, United States
- Palo Alto Medical Foundation — Palo Alto, California, United States
- University of California Davis Cancer Center — Sacramento, California, United States
- Kaiser Permanente Medical Office -Vandever Medical Office — San Diego, California, United States
- Aurora Presbyterian Hospital — Aurora, Colorado, United States
- Boulder Community Hospital — Boulder, Colorado, United States
- Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
- St. Anthony Central Hospital — Denver, Colorado, United States
- Porter Adventist Hospital — Denver, Colorado, United States
- Presbyterian - St. Luke's Medical Center — Denver, Colorado, United States
- St. Joseph Hospital — Denver, Colorado, United States
- Rose Medical Center — Denver, Colorado, United States
- CCOP - Colorado Cancer Research Program — Denver, Colorado, United States
- Swedish Medical Center — Englewood, Colorado, United States
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center — Grand Junction, Colorado, United States
- North Colorado Medical Center — Greeley, Colorado, United States
- Sky Ridge Medical Center — Lone Tree, Colorado, United States
- Hope Cancer Care Center at Longmont United Hospital — Longmont, Colorado, United States
- McKee Medical Center — Loveland, Colorado, United States
- Regional Medical Center — Anniston, Alabama, United States
Full record on ClinicalTrials.gov
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