Clinical Trial VICCHEM1289

Title

Phase III, Multicenter, Randomized, Trial of CPX-351 (Cytarabine: Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients 60-75 Years of Age with Untreated High Risk (Secondary) AML

Principal Investigator(s)

Stephen Strickland

Details

  • Protocol No. VICCHEM1289
  • Open Date: 01/04/2013
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: - To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 years) with high risk (secondary) AML. The primary efficacy endpoint will be overall survival. - To confirm the safety of CPX-351
  • Disease Sites: Leukemia
  • Therapies: Chemotherapy - cytotoxic
  • Drugs: CPX-351; Cytarabine (ARA-C); Daunorubicin (Daunomycin)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01696084
  • Secondary Protocol No: CLTR0310-301

Description

Eligibility

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