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.

Trial Profile

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jun 2015

At a glance

  • Drugs Clofarabine (Primary) ; Cytarabine (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms CLASSIC-1; CLASSIC-I
  • Sponsors Genzyme Corporation
  • Most Recent Events

    • 05 Jul 2012 EudraCT reports actual initiation date 24 Sep 2008.
    • 19 May 2012 Planned number of patients changed from 325 to 376 as reported by European Clinical Trials Database record.
    • 07 May 2012 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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