CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Cyclophosphamide +2 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.

Search/NCT00727415
NCT00727415Phase 2Completed
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A Prospective Multicenter Pilot Trial to Evaluate the Efficacy of a Treatment With Fludarabine, Cyclophosphamide, Lenalidomide (FCL) for Advanced Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Patients.

Gruppo Italiano Malattie EMatologiche dell'Adulto·interventional·Posted Aug 4, 2008·Updated Jan 22, 2019

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide, Fludarabine phosphate, and 1 other intervention for Chronic Lymphocytic Leukemia. Completed, enrolled 42 participants across 23 sites.

Detailed Summary

This is a phase I - II multicenter, non-comparative, open label study in patients with previously treated CLL aimed at defining the MTD of Lenalidomide given in combination with Fludarabine, Cyclophosphamide and at evaluating the (CR) rate of FC given in combination with the MTD of Lenalidomide (FCL).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesItaly
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 4, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 17.9 years ago

Interventions

Cyclophosphamidedrug

All patients will receive six monthly courses of FCL schedule consisting of three days of Fludarabine and Cyclophosphamide administration (d1-d3) combined with 14 days of Lenalidomide administration (d1-d14).

Fludarabine phosphatedrug

All patients will receive six monthly courses of FCL schedule consisting of three days of Fludarabine and Cyclophosphamide administration (d1-d3) combined with 14 days of Lenalidomide administration (d1-d14).

Lenalidomidedrug

All patients will receive six monthly courses of FCL schedule consisting of three days of Fludarabine and Cyclophosphamide administration (d1-d3) combined with 14 days of Lenalidomide administration (d1-d14). In the first phase of the study, the dose of Lenalidomide given with FC will be gradually escalated to reach the MTD. In the second phase of the study, FC will be given in combination with the Lenalidomide escalated to the MTD or the maximum planned dose.