CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
Fludarabine Phosphate +2 moredrug
Likely dose
Fludarabine Phosphate 25 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/NCT00794820
NCT00794820Phase 2Completed
CompareCT.gov

Fludarabine, Cyclophosphamide, and Multiple Dose Rituximab as Frontline Therapy in Chronic Lymphocytic Leukemia (CLL)

M.D. Anderson Cancer Center·interventional·Posted Nov 20, 2008·Updated May 8, 2018

In Brief

A Phase 2 clinical trial evaluating Fludarabine Phosphate, Cyclophosphamide, and 1 other intervention for Chronic Lymphocytic Leukemia. Completed, enrolled 66 participants across 1 site.

Detailed Summary

Primary Objective: * To evaluate the efficacy (combined morphologic and flow remissions) of a combination of fludarabine, cyclophosphamide and multiple dose rituximab as frontline therapy for CLL. Secondary Objective: * To evaluate remission duration and survival.

Study Details

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

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 20, 2008
Enrollment StartDec 1, 2003
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 yearsPosted 17.6 years ago

Interventions

Fludarabine Phosphatedrug

25 mg/m\^2 by vein over 5-30 minutes daily for 3 days (days 2-4)

Cyclophosphamidedrug

250 mg/m\^2 by vein over 60 minutes daily for 3 days (days 2-4)

Rituximabdrug

375 mg/m\^2 by vein for dose 1 (given 1 day prior to chemotherapy) and then 500 mg/m\^2 on days 2-3