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

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Disease Information

Descriptive Information
Brief Title † Efficacy Study of Inecalcitol With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy
Official Title † Efficacy Study of Inecalcitol in Combination With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy
Brief 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.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † overall survival
Secondary Outcome Measure †
Condition † Acute Myelogenous Leukemia
Intervention † DrugInecalcitol
Study Arms / Comparison Groups inecalcitol Two tablets of Inecalcitol 2mg each (total 4mg) taken orally every other day. placebo Two tablets of placebo 2mg each (total 4mg) taken orally every other day
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 110
Start Date † June 2016
Completion Date December 2019
Primary Completion Date June 2018
Eligibility Criteria † Inclusion Criteria: • Patients aged 65 to 400 IU of vitamin D or calcium); - Current use of digitalis; - Current use of drugs which could influence bioavailability of inecalcitol (such as magnesium-containing antacids, bile-resin binders); - Use of any other experimental drug or therapy or vitamin D supplementation within 4 weeks of randomization; - Known HIV; - Patients who are eligible for intensive induction therapy with curative intent; - Refractory congestive heart failure; - Active infection resistant to anti-infective therapy; - Documented pulmonary disease with DLCO ≤ 65% or FEV1≤ 65%, or dyspnea at rest or requiring oxygen, or any pleural neoplasm or uncontrolled lung neoplasm; - Liver cirrhosis Child B or C or acute viral hepatitis; - Current mental illness requiring psychiatric hospitalization, institutionalization or intensive outpatient management, or current cognitive status that produces dependence (as confirmed by the specialist) not controlled by the caregiver; - Uncontrolled neoplasia;
Gender All
Ages 65 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Shankar Srinivasan, PhD, +1-2246221775, ssrinivasan@hybrigenics.com
Location Countries † France
Administrative Information
NCT ID † NCT02802267
Organization ID ICT8
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Hybrigenics Corporation
Collaborators ††
Investigators † Principal Investigator: Jean-Francois Dufour-Lamartinie, MD, Hybrigenics Corporation
Information Provided By
Verification Date February 2017
First Received Date † June 13, 2016
Last Updated Date February 22, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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