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Clinical trial

Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia (301)

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Last updated:1st Nov 2012
Identifier: NCT01696084

To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint will be overall survival.

Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 309 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date: November 2012
Actual Primary Completion Date: March 2016
Estimated Study Completion Date: November 2019

- Experimental:
Arm A (CPX-351)
- Active Comparator: Arm B (7+3)

Category Value
Date last updated at source 2018-02-27
Study type(s) Interventional
Expected enrolment 309
Study start date 2012-11-01
Estimated primary completion date 2016-03-01

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