Efficacy Study of Inecalcitol With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy
NCT ID: NCT02802267
Last Updated: 2017-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
110 participants
INTERVENTIONAL
2016-06-30
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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inecalcitol
Two tablets of Inecalcitol 2mg each (total 4mg) taken orally every other day.
Inecalcitol
vitamin D receptor agonist
placebo
Two tablets of placebo 2mg each (total 4mg) taken orally every other day
Placebo Oral Tablet
placebo
Interventions
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Inecalcitol
vitamin D receptor agonist
Placebo Oral Tablet
placebo
Eligibility Criteria
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Inclusion Criteria
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 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;
65 Years
ALL
No
Sponsors
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Hybrigenics Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Francois Dufour-Lamartinie, MD
Role: PRINCIPAL_INVESTIGATOR
Hybrigenics Corporation
Locations
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Scripps Health
San Diego, California, United States
Georgia Cancer Center-Augusta University
Augusta, Georgia, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States
Duke Cancer Institute, Duke Univ Medical Center
Durham, North Carolina, United States
University of Texas; M D Anderson Cancer Center
Houston, Texas, United States
ProHealth Care Inc
Waukesha, Wisconsin, United States
Necker Hospital- APHP
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Marin Xavier, M.D.
Role: primary
Jeremy M Pantin, M.D.
Role: primary
David Rizzieri, M.D.
Role: primary
Jorge Cortes, M.D.
Role: primary
Olivier Hermine, MD, PhD
Role: primary
Other Identifiers
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ICT8
Identifier Type: -
Identifier Source: org_study_id
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