Who is sponsoring NCT00254163?

NCT00254163 is sponsored by US Oncology Research.

What condition does NCT00254163 study?

NCT00254163 studies B-Cell Chronic Lymphocytic Leukemia.

What drugs are being tested in NCT00254163?

Interventions: Fludarabine, Cyclophosphamide, Rituximab, Pentostatin.

What is the status of NCT00254163?

NCT00254163 is currently COMPLETED.

Last reviewed 2016-09-15 · How we verify

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

NCT00254163 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	US Oncology Research
Phase	Phase 3
Status	COMPLETED
Enrolment	184
Start date	2003-12
Completion	2011-09

Conditions

B-Cell Chronic Lymphocytic Leukemia

Interventions

Fludarabine
Cyclophosphamide
Rituximab
Pentostatin

Primary outcomes

Infection Rate — 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity
infection=febrile events requiring treatment

Countries

United States