Who is sponsoring NCT00086580?

NCT00086580 is sponsored by Genzyme, a Sanofi Company.

What drugs are being tested in NCT00086580?

Interventions in NCT00086580: FluCAM [Fludara + Campath], fludarabine phosphate.

What condition does NCT00086580 study?

NCT00086580 studies B-Cell Chronic Lymphocytic Leukemia.

Is NCT00086580 still recruiting?

NCT00086580 is currently completed. Last updated 10 February 2014.

Are results published for NCT00086580?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2014-02-10 · How we verify

NCT00086580

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 10 February 2014

What this trial tests

Phase 3 trial testing FluCAM [Fludara + Campath] in B-Cell Chronic Lymphocytic Leukemia in 335 participants. Completed in 1 June 2010.

Timeline

1 July 2004

Primary endpoint
1 June 2010

1 June 2010

Quick facts

Lead sponsor	Genzyme, a Sanofi Company
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	335
Start date	1 July 2004
Primary completion	1 June 2010
Estimated completion	1 June 2010
Sites	48 locations across United States, Austria, Bulgaria, Canada, Croatia, France, Germany, Greece

Drugs / interventions tested

FluCAM [Fludara + Campath] — full drug profile →
fludarabine phosphate (FLUDARABINE PHOSPHATE) — full drug profile →

Conditions studied

B-Cell Chronic Lymphocytic Leukemia — all drugs for B-Cell Chronic Lymphocytic Leukemia →

Sponsor

Genzyme, a Sanofi Company — full company profile →

Who can join

18 and older, any sex, with B-Cell Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) Assessment
Time frame: Up to 6 years
Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months.

Sponsor's own description

This is a Phase 3, prospective, multicenter, open-label, randomized, controlled study to evaluate and compare the efficacy and safety of fludarabine plus alemtuzumab versus fludarabine alone as second-line therapy for patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). Patients who meet all eligibility criteria and sign the informed consent document may be entered on the study.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Fludarabine plus alemtuzumab versus fludarabine alone in patients with previously treated chronic lymphocytic leukaemia: a randomised phase 3 trial.
Elter T, Gercheva-Kyuchukova L, Pylylpenko H, Robak T, et al · · 2011 · cited 64× · PMID 21992852 · DOI 10.1016/s1470-2045(11)70242-x
Alemtuzumab for patients with chronic lymphocytic leukaemia.
Skoetz N, Bauer K, Elter T, Monsef I, et al · · 2012 · cited 19× · PMID 22336834 · DOI 10.1002/14651858.cd008078.pub2

Verify or expand the search:

Other recruiting trials for B-Cell Chronic Lymphocytic Leukemia

Currently open trials in the same condition.

NCT06364423 — Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Leukemias · Phase 1, PHASE2 · recruiting
NCT05797233 — Trial of Anti-CD19 and Anti-CD20 Bicistronic Chimeric Antigen Receptor T Cells for Treating B-Cell Malignancies · Phase 1 · active not recruiting

Other Genzyme, a Sanofi Company trials

Trials by the same sponsor.

NCT06666413 — China Post-approval Commitment (PAC) Study of Avalglucosidase Alfa in Participants With IOPD · Phase 4 · recruiting
NCT05164055 — Avalglucosidase Alfa French Post-trial Access for Participants With Pompe Disease (PTA Avalglucosidase) · Phase 4 · active not recruiting
NCT05134571 — China Post-marketing Surveillance (PMS) Study of Aldurazyme® · Phase 4 · completed
NCT05054387 — China Post-marketing Surveillance (PMS) Study of Fabrazyme® · Phase 4 · completed
NCT04676373 — Study to Evaluate Efficacy and Safety in Chinese Patients With Late Onset Pompe Disease With Alglucosidase Alfa Treatmen · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00086580 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Genzyme, a Sanofi Company
Last refreshed: 10 February 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00086580.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing