Clinical trial

A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or…

NCT00317642 · Genzyme, a Sanofi Company, Industry · Completed

Key facts

NCT number NCT00317642
Title A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I)
Official title A Phase III Randomized, Double-blind, Controlled Study Comparing Clofarabine and Cytarabine Versus Cytarabine Alone in Adult Patients 55 Years and Older With Acute Myelogenous Leukemia (AML) Who Have Relapsed or Are Refractory After Receiving up to Two Prior Induction Regimens
Lead sponsor Genzyme, a Sanofi Company, Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Acute Myelogenous Leukemia
Intervention type Drug
Interventions clofarabine (IV formulation), placebo, cytarabine
Enrollment 326
Start date Aug 1, 2006
Primary completion Jan 1, 2012
Completion Jan 1, 2012
First posted Apr 25, 2006
Last update posted Apr 14, 2014
Countries Canada, France, Germany, Italy, United States

At a glance

  • 10–99 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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