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

June 30, 2017 updated by: Hybrigenics Corporation

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Recruiting
        • Necker Hospital- APHP
        • Contact:
          • Olivier Hermine, MD, PhD
  • United States
    • California
      • San Diego, California, United States, 92103
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Georgia Cancer Center-Augusta University
        • Contact:
          • Jeremy M Pantin, M.D.
        • Contact:
    • Nevada
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • New Mexico Cancer Care Alliance
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cecilia Arana-Yi, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Institute, Duke Univ Medical Center
        • Contact:
          • David Rizzieri, M.D.
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas; M D Anderson Cancer Center
        • Contact:
          • Jorge Cortes, M.D.
        • Contact:
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Patients aged 65 to < 75 years with at least one non severe comorbidity ie disease or syndrome with mild to moderate clinical or diagnostic observations or lab abnormalities which could increase the risk of toxicity and/or early death of intensive chemotherapy in the opinion of the investigator and are not contra-indicated for non-intensive chemotherapy.

or ≥ 75 years with or without any comorbidity at the time of the informed consent signature;

• Newly diagnosed, untreated de novo or secondary AML according to WHO classification;

Exclusion Criteria:

  • Prior or current treatment with chemotherapy for any myeloid disorder (excluding hydroxyurea) or radiotherapy for extramedullary involvement within 2 weeks of randomization;
  • Prior treatment with decitabine, azacitidine, or cytarabine;
  • Prior malignancies for 5 years with exception of basal cell, squamous cell carcinoma of the skin, or carcinoma " in situ " of the cervix or breast;
  • Chronic myelogenous or acute promyelocytic leukaemia;
  • Known CNS involvement;
  • Patient eligible to bone marrow or stem cell transplant;
  • WBC ≥ 30.000/mm3;
  • Impaired renal function with Creatinine clearance < 30 mL/min/1.73m² according to the MDRD formula;
  • Serum bilirubin ≥ 2.5 x ULN and/or AST and/or ALT ≥ 2.5 x ULN (upper limit of normal value);
  • Calcemia ≥ 2.65 mmol/L (106 mg/L) at screening assessment (corrected with albuminemia);
  • History of diseases known to be associated with calcium disorders: ongoing hyperparathyroidism, sarcoidosis….;
  • Presence or history of symptomatic kidney stones in the last 5 years;
  • Hypersensitivity to any of the excipients of decitabine (Potassium dihydrogen phosphate (E340) ; Sodium hydroxide (E524) ; Hydrochloric acid (for pH adjustment) or to the excipient of inecalcitol tablets (lactose);
  • Current use of drugs known to influence serum calcium (such as thiazide diuretics, teriparatide, calcitonin and multivitamin supplements containing > 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: inecalcitol
Two tablets of Inecalcitol 2mg each (total 4mg) taken orally every other day.
Drug: Inecalcitol
vitamin D receptor agonist
Placebo Comparator: placebo
Two tablets of placebo 2mg each (total 4mg) taken orally every other day
Drug: Placebo Oral Tablet
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hybrigenics Corporation

Investigators

  • Principal Investigator: Jean-Francois Dufour-Lamartinie, MD, Hybrigenics Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimate)

June 16, 2016

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICT8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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