NCT00254163

Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients

A Prospective, Randomized, Open Label, Phase III Trial of Fludarabine, Cyclophosphamide, and Rituximab vs. Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-cell Chronic Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: US Oncology Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to find out what effects (good and bad) the combination of Nipent+Cytoxan+Rituxan has on CLL cancer compared to Fludara+Cytoxan+Rituxan. While all of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of other cancers, these combinations are experimental for the treatment of CLL.

Conditions

• B-Cell Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Fludarabine
DRUG	Cyclophosphamide
DRUG	Rituximab
DRUG	Pentostatin

Timeline

• Start date: 2003-12-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2005-11-15
• Last updated: 2016-11-03
• Results posted: 2016-11-03

Locations

11 sites across 1 country: United States