NCT02802267

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2016

Typical duration for phase_2

Geographic Reach
2 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

2.5 years

First QC Date

June 13, 2016

Last Update Submit

June 30, 2017

Conditions

Acute Myelogenous Leukemia

Outcome Measures

Primary Outcomes (1)

  • overall survival

    24 months

Study Arms (2)

inecalcitol

EXPERIMENTAL

Two tablets of Inecalcitol 2mg each (total 4mg) taken orally every other day.

Drug: Inecalcitol

placebo

PLACEBO COMPARATOR

Two tablets of placebo 2mg each (total 4mg) taken orally every other day

Drug: Placebo Oral Tablet

Interventions

InecalcitolDRUG

vitamin D receptor agonist

inecalcitol
Placebo Oral TabletDRUG

placebo

placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Scripps Health

San Diego, California, 92103, United States

RECRUITING

Georgia Cancer Center-Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

RECRUITING

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, 87106, United States

RECRUITING

Duke Cancer Institute, Duke Univ Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

University of Texas; M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

ProHealth Care Inc

Waukesha, Wisconsin, 53188, United States

NOT YET RECRUITING

Necker Hospital- APHP

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

inecalcitol

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Jean-Francois Dufour-Lamartinie, MD

    Hybrigenics Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shankar Srinivasan, PhD

CONTACT

+1-2246221775ssrinivasan@hybrigenics.com

Jean-Francois Dufour-Lamartinie, MD

CONTACT

+33-158103805jfdufour@hybrigenics.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 16, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

July 2, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(7)FR(1)