At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 184 enrolled
Drug / intervention
Fludarabine +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Fludarabine, Cyclophosphamide, and 2 other interventions for B-Cell Chronic Lymphocytic Leukemia. Completed, enrolled 184 participants across 11 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-Cell Chronic Lymphocytic Leukemia
CountriesUnited States
CollaboratorsAstex Pharmaceuticals, Inc.
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2003
First PostedNov 2005
Primary CompletionSep 2011
TodayJul 2026
First PostedNov 15, 2005
Enrollment StartDec 1, 2003
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 20.6 years ago
Interventions
Fludarabinedrug
Cyclophosphamidedrug
Rituximabdrug
Pentostatindrug