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Efficacy Study of Inecalcitol With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy

NCT02802267 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2017-07-02

No results posted yet for this study

Summary

Evaluate the effect of the addition of inecalcitol to decitabine treatment on overall survival in previously untreated AML patients aged 65 years or more who are randomly assigned to receive decitabine with or without inecalcitol.

Conditions

  • Acute Myelogenous Leukemia

Interventions

DRUG

Inecalcitol

vitamin D receptor agonist

DRUG

Placebo Oral Tablet

placebo

Sponsors & Collaborators

  • Hybrigenics Corporation

    lead INDUSTRY

Principal Investigators

  • Jean-Francois Dufour-Lamartinie, MD · Hybrigenics Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-12-31
Completion
2019-12-31

Countries

  • United States
  • France

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 NCT02802267 on ClinicalTrials.gov