CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
Fludarabine +2 moredrug
Likely dose
Cyclophosphamide 20 mgfrom 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.

Search/NCT00280241
NCT00280241Phase 2Completed
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Phase II Clinical Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia

University of Pittsburgh·interventional·Posted Jan 20, 2006·Updated Feb 4, 2016

In Brief

A Phase 2 clinical trial evaluating Fludarabine, Cyclophosphamide, and 1 other intervention for Chronic Lymphocytic Leukemia. Completed, enrolled 65 participants across 1 site.

Detailed Summary

This research study will look at the effects (good or bad) of administering cyclophosphamide, fludarabine, and rituximab. Clinical studies with combination therapy have shown higher response rates than using single drugs, and this study will evaluate the side effects and effectiveness of this combination.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesUnited States
CollaboratorsGenentech, Inc., Biogen

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 20, 2006
Enrollment StartJun 1, 2004
Primary CompletionFeb 1, 2008
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 20.4 years ago

Interventions

Fludarabinedrug

Fludarabine is usually administered by IV infusion over 30 minutes or longer.

Cyclophosphamidedrug

The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.

Rituximabdrug

First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.