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Study of Elacytarabine Versus Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia (AML)

NCT01147939 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2013-09-27

No results posted yet for this study

Summary

The purpose of the study is to assess the efficacy and safety of elacytarabine versus investigator's choice treatment in patients with relapsed or refractory acute myeloid leukemia (AML).

Conditions

  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

Elacytarabine

Elacytarabine 2000 mg/m2/d administered as a continuous intravenous infusion (CIV) in a d 1-5 q3w cycle.

DRUG

Investigator's Choice

E.g. cytarabine single agent/combinations, hypomethylating agents, best supportive care (BSC)

Sponsors & Collaborators

  • Clavis Pharma

    lead INDUSTRY

Principal Investigators

  • David Rizzieri, MD · Duke University Medical Center, Durham, NC, USA

  • Francis J Giles, MD, PhD · Cancer Therapy & Reseach Center at the University of Texas Health Science Center San Antonio, TX, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-02-28
Completion
2013-06-30

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Ireland
  • Italy
  • Norway
  • Poland
  • Romania
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01147939 on ClinicalTrials.gov