Completed PHASE3 INTERVENTIONAL 2-arm NCT00086580

Fludarabine (Fludara®) Plus Alemtuzumab (CAMPATH®, MabCampath®) vs Fludarabine Alone in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients

A Phase III Randomized Trial to Evaluate the Efficacy and Safety of Second-Line Therapy With Fludarabine Plus Alemtuzumab vs. Fludarabine Alone in Patients With B-Cell Chronic Lymphocytic Leukemia

Sponsor: Genzyme, a Sanofi Company

Conditions B-Cell Chronic Lymphocytic Leukemia

Interventions FluCAM [Fludara + Campath] fludarabine phosphate

Updated 7 times since 2017 Last updated: Feb 10, 2014 Started: Jul 31, 2004 Primary completion: Jun 30, 2010 Completion: Jun 30, 2010

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates B-Cell Chronic Lymphocytic Leukemia and is currently completed. Genzyme, a Sanofi Company leads this study, which shows 7 recorded versions since 2004 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Jul 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Genzyme, a Sanofi Company

Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Berlin, Germany , Bucharest, Romania , Cantanzaro, Italy , Cherkasy, Ukraine , Cologne, Germany , Dnipro, Ukraine , Donetsk, Ukraine , Fort Myers, United States , Goudi, Greece , Graz, Austria and 32 more locations